RUGBY CAPSAICIN CREAM- capsaicin cream 
Rugby Laboratories

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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Rugby 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

Stop Use and Ask Doctor if:

Keep Out of the Reach of Children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) 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, Polyoxyethylene lauryl ether, Purified Water, stearic acid.

Questions

Call 1-800-645-2158

Distributed By:

RUGBY®LABORATORIES

Livonia, MI 48152

www.rugbylaboratories.com

rev. 09/21 R-167 Re-order No. 370818

Other Information

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

Packaging

5882244 CAH RGB Capsaicin Cream 42.5g CDER

RUGBY CAPSAICIN CREAM 
capsaicin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1264
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
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ETHYLPARABEN (UNII: 14255EXE39)  
MINERAL OIL (UNII: T5L8T28FGP)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PETROLATUM (UNII: 4T6H12BN9U)  
LAURETH-15 (UNII: 002FR4N8OV)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-1264-561 in 1 BOX02/17/2020
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 not finalpart34802/17/2020
Labeler - Rugby Laboratories (079246066)
Registrant - Trifecta Pharmaceuticals USA LLC (079424163)

Revised: 6/2023
Document Id: ff4b6054-8db3-b96f-e053-6294a90a5698
Set id: 9eca34f1-e91a-3ac1-e053-2a95a90a9bd9
Version: 3
Effective Time: 20230629
 
Rugby Laboratories