Clindavix (Page 2 of 2)

OVERDOSAGE

Topically applied Clindamycin Phosphate Topical Solution USP, 1% can be absorbed in sufficient amounts to produce systemic effects (see WARNINGS).

DOSAGE AND ADMINISTRATION

Apply a thin film of Clindamycin Phosphate Topical Solution USP, 1% to the affected area twice daily. Keep container tightly closed.

HOW SUPPLIED

Clindamycin Phosphate Topical Solution USP, 1% is available as follows:

60 mL applicator bottle (NDC 45802- 562 -02)

STORAGE

Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Protect from freezing.

Manufactured By

Perrigo

Bronx, NY 10457

Distributed By Perrigo

Allegan, MI 49010

www.perrigo.com

Rev 05-18

: 7F100 RC J4

Dynashield -Active Ingredients

Active Ingredient Purpose

Zinc Oxide 2% Diaper Rash

Dimethicone 1.8% Skin Protectant

Dynashield-When using

For External Use Only.

Do not get in eyes.

Dynashield-Stop Use

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again in a few days, consult a physician
  • over large areas of the body
  • if you are allergic to any of these ingredients

Dynashield- Keep out of reach of children

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

Dynashield- Purpose

  • Helps treat and prevent diaper rash
  • Dries the oozing and weeping of;
  • poison ivy
  • poison oak
  • poison sumac

Dynashield-Dosage

For poison ivy, oak and sumac:

  • Apply ointment liberally as often as needed

For diaper Rash:

  • change wet and soiled diapers promptly
  • clean the diaper area and allow to dry
  • apply ointment liberally with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

Dynashield-Other Information

  • Do not use if seal is punctured or not visible
  • Store at room temperature 15 0 - 30 0 C (59 0 - 86 0 F)
  • avoid excessive heat
  • contains color additives including FDC yellow # 5 (Tartrazine)

Dynashield-Indications

Indications: For use as a general skin protectant and diaper rash.

Dynashield-Inactive

Aloe Vera Leaf, Alpha-Tocopherol, Ceteth-20, Cetostearyl Alcohol, Cetyl Alcohol, Cholecalciferol, Glycerin, Lanolin, Lavender perfume, Methylparaben, Mineral Oil, Petrolatum, Propylparaben, Trolamine, Vitamin A, Water

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL — CARTON

label
(click image for full-size original)

CLINDAVIX
clindamycin phosphate, dimethicone kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72275-741
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72275-741-77 1 KIT in 1 CARTON None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 0 BOTTLE, WITH APPLICATOR 1 mL
Part 2 0 TUBE 1 g in 114
Part 1 of 2
CLINDAMYCIN PHOSPHATE
clindamycin phosphate solution
Product Information
Item Code (Source) NDC:45802-562
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLINDAMYCIN PHOSPHATE (CLINDAMYCIN) CLINDAMYCIN 10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
PROPYLENE GLYCOL
ISOPROPYL ALCOHOL
SODIUM HYDROXIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 60 mL in 1 BOTTLE, WITH APPLICATOR None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA064050 09/17/2013
Part 2 of 2
DYNASHIELD WITH DIMETHICONE
zinc oxide ointment
Product Information
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIMETHICONE (DIMETHICONE) DIMETHICONE 1.8 g in 100 g
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 2 g in 100 g
Inactive Ingredients
Ingredient Name Strength
LANOLIN
ALOE VERA LEAF
WATER
CHOLECALCIFEROL
CETOSTEARYL ALCOHOL
CETYL ALCOHOL
PETROLATUM
TROLAMINE
LAVANDULA ANGUSTIFOLIA FLOWER
PROPYLPARABEN
GLYCERIN
CETETH-20
METHYLPARABEN
VITAMIN A
FD&C YELLOW NO. 5
MINERAL OIL
Packaging
# Item Code Package Description Multilevel Packaging
1 114 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 10/01/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA064050 09/17/2013
Labeler — Primary Pharmaceuticals, Inc. (066126126)
Establishment
Name Address ID/FEI Operations
Rainbow Gold 800695152 repack (72275-741)

Revised: 12/2020 Primary Pharmaceuticals, Inc.

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