CVS ROLL-ON- capsaisin 0.1% gel 
CVS

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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CVS Health Capsaisin Roll-on 0.1%

Capsaicin 0.1%

Topical Analgesic

Temporarily relieves minor pain associated with arthritis, simple backache, sprains, bruises, muscle strains, and cramps.

For external use only.

When using this product do not bandage tightly or cover treated area, do not use with heating pad, avoid contact with eyes and mucous membranes, do not apply to wounds, damaged, broken or irritated skin, a transient burning sensation may occur upon application but generally disappears in several days, if severe burning occurs, discontinue use immediately, do not expose the area treated with product to heat or direct sunlight.

Stop use and ask a doctor if condition worsens, symptoms last more than 7 days or clear up and occur again within a few days, redness is present, or irritation develops.

Ask a health professional before use.

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

Adults and children of 18 years: apply to affected area, massage into 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 or younger: ask a doctor.

Alcohol denat., aminomethyl propanol, carbomer, glycerin, propylene glycol, water.

Label

CVS ROLL-ON 
capsaisin 0.1% gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-265
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALCOHOL (UNII: 3K9958V90M)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51316-265-0271 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/22/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/22/2022
Labeler - CVS (062312574)
Registrant - Derma Care Research Labs, LLC (116817470)
Establishment
NameAddressID/FEIBusiness Operations
Derma Care Research Labs, LLC116817470manufacture(51316-265)

Revised: 5/2023
Document Id: fb711520-65de-35d7-e053-6294a90a0ef8
Set id: e8812c49-335e-61ea-e053-2995a90a17aa
Version: 2
Effective Time: 20230511
 
CVS