CVS CAPSAICIN - capsaicin cream 
CVS Pharmacy

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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DRUG FACTS

Active ingredient                                 Purpose

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



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


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

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.


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 Ingredients

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


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CVS CAPSAICIN 
capsaicin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-622
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN75 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-622-651 in 1 CARTON
142.5 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34807/08/2010
Labeler - CVS Pharmacy (062312574)
Registrant - Pharma Pac, LLC (140807475)
Establishment
NameAddressID/FEIBusiness Operations
Pharma Pac, LLC140807475manufacture

Revised: 7/2010
Document Id: fb869713-a2be-4644-bbf2-6e894ea30fef
Set id: b0548b21-bac7-43f1-a9ff-c4aa7b4e52b4
Version: 1
Effective Time: 20100708
 
CVS Pharmacy