CAPSAICIN- capsaicin cream 
Asclemed USA, Inc.

----------

Capsaicin Cream 0.1%

Drug Facts

Active Ingredient

Capsaicin 0.1%

Purpose

Topical Analgesic

Warnings

For external use only:Read all warnings and directions before use. Test first on small area of skin.

Do not use:

When using this product:

Stop Use and Ask Doctor

Stope Use and Ask Doctor if:

Keep Out of the Reach of Children

Keep out of the reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Uses

Temporarily relieves minor aches and pains of muscles and joints due to:

Directions

Adults and Children 18 years of age and older:

Children under 18 years:

Ask a doctor

Inactive Ingredients

Aloe barbadensis leaf extract, cetyl alcohol, glyceryl stearate SE, mineral oil, PEG-100 stearate, peppermint oil, phenoxyethanol, propylene glycol, purified water, stearyl alcohol, white petrolatum, xanthan gum

Questions

Questions? Comments?

1-855-361-3993

Other Information

Store at room temperature 15°-30°F (59°-86°F)

Relabeled by:

Enovachem PHARMACEUTICALS

Torrance, CA 90501

Packaging

label

CAPSAICIN 
capsaicin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76420-753(NDC:50268-198)
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
CETYL ALCOHOL (UNII: 936JST6JCN)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
XANTHAN GUM (UNII: TTV12P4NEE)  
MINERAL OIL (UNII: T5L8T28FGP)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
WATER (UNII: 059QF0KO0R)  
PETROLATUM (UNII: 4T6H12BN9U)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76420-753-421 in 1 CARTON06/20/2024
142.5 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01712/08/2022
Labeler - Asclemed USA, Inc. (059888437)
Establishment
NameAddressID/FEIBusiness Operations
ASCLEMED USA INC. DBA ENOVACHEM059888437relabel(76420-753)

Revised: 6/2024
Document Id: 1b4cad2b-3896-f700-e063-6394a90a2fa5
Set id: 97d506bd-3215-4e2e-9914-af1c174dd4ab
Version: 1
Effective Time: 20240620
 
Asclemed USA, Inc.