CVS CAPSAICIN- capsaicin cream

CVS Capsaicin by

Drug Labeling and Warnings

CVS Capsaicin by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy, Pharma Pac, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient                                 Purpose

Capsaicin 0.1%............................................Topical analgesic

PURPOSE

Uses for the temporary relieves of minor aches and pains of muscles and joints associated with:
- arthritis - simple backache - strains - bruises

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If case of overdose or allergic reaction, seek medical attention or contact
a Poison Control Center right away.

INDICATIONS & USAGE

Uses for the temporary relieves of minor aches and pains of muscles and joints associated with:
- arthritis - simple backache - strains - bruises

WARNINGS

Warnings

For external use only

When using this product

- use only as directed - do not apply to wounds, damaged, broken or irritated skin - avoid contact
with the eyes or mucous membranes - a slight burning sensation may occur upon application, but
generally disappears in several days - if severe burning occurs, discontinue use - do not expose
the treated area to heat or direct sunlight - do not bandage - do not use with heating pad

Stop use and consult a dentist or doctor if:

-  condition worsens - symptoms persist for more than 7 days or clear up and occur again within a few days
- redness is present - irritation develops

Keep out of the reach of children.In case of overdose or allergic reaction,
seek medical attention or contact a Poison Control Center right away.

If pregnant or breast feeding, ask a health professional before use.

DOSAGE & ADMINISTRATION

Directions 

Adults and children over 18 years
- apply to affected area
- Massage into the painful area until thoroughly absorbed
- Repeat as necessary, but no more than 3 to 4 times daily
- WASH HANDS WITH SOAP AND WATER AFTER APPLYING

Children 18 years and younger: ask a doctor.

INACTIVE INGREDIENT

Inactive Ingredients

purified water, petrolatum, cetyl alcohol glyceryl stearate, PEG-40 stearate, isopropyl myristate, sorbitol, PEG-2 stearate, benzyl alcohol

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CVS CAPSAICIN 
capsaicin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59779-622
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	75 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIGLYCOL STEARATE (UNII: 94YQ11Y95F)
PETROLATUM (UNII: 4T6H12BN9U)
POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CETYL ALCOHOL (UNII: 936JST6JCN)
SORBITOL (UNII: 506T60A25R)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59779-622-65	1 in 1 CARTON
1		42.5 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part348	07/08/2010

Labeler - CVS Pharmacy (062312574)

Registrant - Pharma Pac, LLC (140807475)

Establishment
Name	Address	ID/FEI	Business Operations
Pharma Pac, LLC		140807475	manufacture