CAPSAICIN CREAM- capsaicin cream 
Trifecta Pharmaceuticals USA LLC

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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Globe Capsaicin Cream

Drug Facts

Active Ingredient

Capsaicin 0.1%

Purpose

Topical Analgesic

Warnings

For external use only: TEST FIRST ON SMALL AREA OF SKIN.

When using this product:

Stop Use and Ask Doctor

Stope Use and Ask Doctor if:

Keep Out of the Reach of Children

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

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with:

If Pregnant or Breast Feeding

Ask a doctor before use

Directions

Adults and Children over 18 years:

Children 18 years and younger:

Ask a doctor

Inactive Ingredients

Aloe barbadensis leaf juice, Cetostearyl alcohol, Ethylparaben, Glycerin, Glyceryl monostearate, Mineral Oil, Petrolatum, Purified Water, Polyoxyethylene Lauryl Ether, Stearic Acid

Other Information

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

This product is not manufactured or distributed by Chattem, distributor of Capzaicin-HP arthritis pain relief.

Questions

Questions or Comments

Please call Toll Free 1-888-296-9067

Other Information

Distributed by

Trifecta Pharmaceuticals USA

101 NE Third Aveue, Suite 1500

Fort Lauderdale, FL 33301

www.trifecta-pharma.com

globe-capsaicin-60g-CDER

CAPSAICIN CREAM 
capsaicin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-103
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
LAURETH-23 (UNII: N72LMW566G)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ETHYLPARABEN (UNII: 14255EXE39)  
MINERAL OIL (UNII: T5L8T28FGP)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69396-103-021 in 1 BOX05/14/2022
160 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/14/2022
Labeler - Trifecta Pharmaceuticals USA LLC (079424163)

Revised: 8/2023
Document Id: 02e86bc1-eb13-b6e7-e063-6294a90a5f27
Set id: def8d341-06a7-0e9b-e053-2995a90a0ad6
Version: 3
Effective Time: 20230814
 
Trifecta Pharmaceuticals USA LLC