BenzoDox 60 Kit (Page 6 of 6)

REFERENCES

1. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Susceptibility Testing; Twenty-third Informational Supplement, CLSI document M100-S23. CLSI document M100S23, Clinical Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne Pennsylvania 19087, USA, 2013.
2. Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard – Ninth Edition. CLSI document M07-A9, Clinical Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne Pennsylvania 19087, USA, 2012.
3. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Disk Diffusion Susceptibility Tests; Approved Standard – Eleventh Edition. CLSI document M02-A11, Clinical Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne Pennsylvania 19087, USA, 2012.
4. Clinical and Laboratory Standards Institute (CLSI). Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria; Approved Guideline – Second Edition. CLSI document M45-A2, Clinical Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne Pennsylvania 19087, USA, 2010.
5. Clinical and Laboratory Standards Institute (CLSI). Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria; Approved Standard – Eighth Edition. CLSI document M11-A8, Clinical Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne Pennsylvania 19087, USA, 2012.
6. Clinical and Laboratory Standards Institute (CLSI). Methods for Mycobacteria, Nocardiae, and Other Aerobic Actinomycetes; Approved Standard – Second Edition. CLSI document M24-A2, Clinical Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne Pennsylvania 19087, USA, 2011.
7. Clinical and Laboratory Standards Institute (CLSI). Methods for Antimicrobial Susceptibility Testing for Human Mycoplasmas; Approved Guideline. CLSI document M43-A, Clinical Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne Pennsylvania 19087, USA, 2011.
8. Friedman JM and Polifka JE. Teratogenic Effects of Drugs. A Resource for Clinicians (TERIS). Baltimore, MD: The Johns Hopkins University Press: 2000: 149-195.
9. Cziezel AE and Rockenbauer M. Teratogenic study of doxycycline. Obstet Gynecol 1997;89:524-528.
10. Horne HW Jr. and Kundsin RB. The role of mycoplasma among 81 consecutive pregnancies: a prospective study. Int J Fertil 1980; 25:315-317.
11. Hale T. Medications and Mothers Milk. 9th edition. Amarillo, TX: Pharmasoft Publishing 2000; 225-226.

Manufactured For:
Elorac, Inc.
Vernon Hills, IL 60061
Made in the USA

Revised: 08/14, Revision 2

10-303

DOXYCYCLINE TABLETS, USP

Rx Only

Advanced Acne Wash (4.4% benzoyl peroxide extended release)

Continous Action for Lasting Results

Dermatologist Developed

3.5 FL OZ (104ml)

Drug Facts

Active Ingredient

Benzoyl peroxide 4.4%

Purpose

Acne treatment

Uses

Treats and helps prevent acne

Warnings

For external use only

Do not use if you

have very sensitive skin

are sensitive to benzoyl peroxide

When using this product

Avoid unnecessary sun exposure and use a sunscreen

Avoid contact with eyes, lips, and mouth

Avoid contact with hair and dyed fabrics, which may be bleached by this product

Skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently.

Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

Stop use and ask a doctor if

irritation becomes severe

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Wet face

Apply to hands then work into a lather and massage gently onto face

Rinse thoroughly and pat dry

Because excessive drying of the skin may occur, start with one application daily, then increase to 2 times daily if needed or as directed by a doctor

If bothersome dryness or peeling occurs, reduce usage to once a day or every other day

If going outside, apply sunscreen after using this product.

If irritation or sensitivity develops, stop use of both products and ask a doctor.

Other information

THIS PRODUCT MAY BLEACH HAIR OR DYED FABRICS

KEEP TIGHTLY CLOSED

Avoid storing at temperatures above 100°F (38°C)

Inactive ingredients

Butyrospermum Parkii (Shea) Butter, C13-14 Isoparaffin, Cocamidopropyl Betaine, Ethylhexylglycerin, Euphorbia Cerifera (Candelilla) Wax, Hydroxyethyl Behenamidopropyl Dimonium Chloride, Laureth-7, Phenoxyethanol, Polyacrylamide, Water

Questions?

1-847-362-8200 MON — FRI 9 AM — 5 PM (CST)

Advanced Acne Wash

Extended — release action for lasting results

Kills bacteria that cause acne

Gentle formula

Manufactured for Elorac, Inc.

Vernon Hills, IL 60061

U.S. Patent No. 6979440

022004-2 07/2015 ©2015 Elorac, Inc.

NDC 42783-635-04
Elorac, Inc.Advanced Acne Wash

PRINCIPAL DISPLAY PANEL

NDC 42783-663-60

BenzoDox 60 Kit

Rx Only

Manufactured for: Elorac, Inc.

Vernon Hills, IL 60061

U.S. Patent No. 6979440

© Elorac, Inc.

BenzoDox™ is a trademark of Elorac, Inc.

020430

08/2015

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NDC 42783-601-60

DOXYCYCLINE TABLETS, USP
100 mg
Rx Only

60 TABLETS

Manufactured for:
Elorac, Inc.Vernon Hills, IL 60061

Rev.07/15, Revision 2 10-302

//medlibrary.org/lib/images-rx/benzodox-60-kit/doxycycline-60-300x97.jpg
(click image for full-size original)

NDC 42783-635-04

Advanced Acne Wash (4.4% Benzoyl Peroxide Extended Release)

Manufactured for Elorac, Inc.

Vernon Hills, IL 60061

U.S. Patent No. 6979440

022004-2 07/2015 © Elorac, Inc.

//medlibrary.org/lib/images-rx/benzodox-60-kit/advanced-acne-wash-300x193.jpg
(click image for full-size original)
BENZODOX 60 KIT doxycycline tablets and advanced acne wash kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42783-663
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42783-663-60 1 KIT in 1 KIT None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 BOTTLE 60
Part 2 1 TUBE 104 mL
Part 1 of 2
DOXYCYCLINE doxycycline tablet, film coated
Product Information
Item Code (Source) NDC:42783-601
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOXYCYCLINE (DOXYCYCLINE ANHYDROUS) DOXYCYCLINE ANHYDROUS 100 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
MAGNESIUM STEARATE
POLYVINYL ALCOHOL
TITANIUM DIOXIDE
POLYETHYLENE GLYCOLS
TALC
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
ALUMINUM OXIDE
Product Characteristics
Color yellow Score no score
Shape OVAL ((caplet)) Size 13mm
Flavor Imprint Code LCI;1338
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42783-601-60 60 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065285 12/08/2005
Part 2 of 2
ADVANCED ACNE WASH benzoyl peroxide liquid, extended release
Product Information
Item Code (Source) NDC:42783-635
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 44 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SHEA BUTTER
C13-14 ISOPARAFFIN
COCAMIDOPROPYL BETAINE
ETHYLHEXYLGLYCERIN
CANDELILLA WAX
HYDROXYETHYL BEHENAMIDOPROPYL DIMONIUM CHLORIDE
LAURETH-7
PHENOXYETHANOL
WATER
Product Characteristics
Color white Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42783-635-04 104 mL in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333D 09/17/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 09/22/2015
Labeler — Elorac, Inc. (832590009)

Revised: 10/2015 Elorac, Inc.

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