Capsinac (Page 7 of 7)

Active ingredient

Capsicum Oleoresin 0.0625% (containing capsaicin 0.025%)

Purpose

Topical Analgesic

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with arthritis, strains, and sprains.

Warnings

For external use only

This is not a face cream. Do not apply to the face.

Do not use if allergic to chili peppers or if past allergic reaction to capsaicin.

Do not apply to wounds or damaged, broken, sunburned, chapped or irritated skin.

Do not bandage tightly.

Do not apply within 1 hour before or after bath, shower, hot tub, sauna or vigorous exercise.

Warm water, perspiration or open pores can intensify the impact of this product and cause a burning sensation.

Do not use with heating pad, hot water bottle or other source of heat. Doing so can increase risk of serious burns.

When using this product

do not get into eyes and avoid contact with other mucous membranes. If contact occurs or if pain, discomfort or skin redness occurs, continually rinse with cool water and seek medical help.

Discontinue use and consult a doctor if

condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days. Stop using product immediately and get medical attention if experiencing burning, pain, swelling, or blistering of the skin. Rare cases of severe burning or blistering have been reported.

If pregnant, breast-feeding, or any medical conditions exist, ask a health professional before use.

Keep out of reach of children and pets.

If swallowed, get medical help or contact a Poison Control Center right away. If inhaled, remove to fresh air. If breathing is difficult, get medical attention immediately.

Directions

  • Rotate pump’s spout counter-clockwise slightly to unlock; clockwise to lock.
  • Before using on children under 18 years of age, consult a physician.
    Apply sparingly to affected area not more than 4 times daily. However, for first use, apply to small area to test for sensitivity or skin reaction.
    Gently massage into the skin until fully absorbed.
    Wash hands with soap and water thoroughly after each application to avoid spreading to the eyes or other sensitive mucous membranes.

Other information

WARNING: FLAMMABLE PRODUCT

Store in a cool well ventilated area away from heat. Keep away from sparks or open flame.

Inactive ingredients

Aloe Barbadensis Leaf Extract, Bisabolol, Carbomer, Caprylyl Glycol, Cetearyl Alcohol, Ceteareth-20, Green Tea (Camellia Sinensis) Leaf Extract, Glycerin, Methylisothiazolinone, PEG-8, Polyglyceryl-3 Oleate, Triethanolamine, Water

Questions or comments ?

Call toll-free1-888-452-9975 or visit us at www.sirclelabs.com

Manufactured for: Sircle Laboratories, LLC, Madison, MS 39110

CAPSINAC Therapy Kit (NDC 73247-201-01)

How Supplied: 1 unit (pack); NDC 73247-201-01

Each kit contains:

1
Diclofenac Sodium 1.5% Topical Solution (150ml bottle)
1
Capsaicin 0.025% Cream (237ml bottle)

*See individual products package insert for information, dosage & administration.

Storage

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

KEEP THIS AND ALL MEDICATION OUT OF REACH OF CHILDREN

Comments or Adverse reactions: Call toll-free 1-866-660-2626 or visit us at www.bodysphere.com

Manufactured for: Bodysphere, LLC, Las Vegas, NV 89120

PRINCIPAL DISPLAY PANEL — Kit Carton

Rx Only
NDC 73247-201-01

CAPSINAC
Therapy Kit

Diclofenac Sodium Topical Solution
(1.5% w/w, 5 fl oz/150mL)

Capsaicin Cream
(Capsaicin 0.025%, 8 fl oz/237mL)

TOPICAL ONLY

BODYSPHERE +MADE IN USA

PRINCIPAL DISPLAY PANEL -- Kit Carton
(click image for full-size original)
CAPSINAC diclofenac sodium and capsaicin kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:73247-201
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:73247-201-01 1 KIT in 1 CARTON None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 BOTTLE 150 mL
Part 2 1 BOTTLE, PUMP 237 mL
Part 1 of 2
DICLOFENAC SODIUM diclofenac sodium solution/ drops
Product Information
Item Code (Source) NDC:51021-250
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Diclofenac Sodium (Diclofenac) Diclofenac Sodium 16.05 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
dimethyl sulfoxide
propylene glycol
alcohol
glycerin
water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51021-250-05 150 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204132 08/20/2015
Part 2 of 2
BIO-SORB capsaicin cream
Product Information
Item Code (Source) NDC:51021-302
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Capsaicin (Capsaicin) Capsaicin 0.025 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
GLYCERIN
TROLAMINE
CETOSTEARYL ALCOHOL
POLYOXYL 20 CETOSTEARYL ETHER
ALOE VERA LEAF
GREEN TEA LEAF
LEVOMENOL
POLYETHYLENE GLYCOL 800
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
POLYGLYCERYL-3 OLEATE
CAPRYLYL GLYCOL
METHYLISOTHIAZOLINONE
Product Characteristics
Color WHITE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51021-302-08 237 mL in 1 BOTTLE, PUMP None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part348 10/20/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204132 11/15/2019
Labeler — Bodysphere, LLC (117131105)

Revised: 08/2020 Bodysphere, LLC

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