RUGBY CAPSAICIN CREAM- capsaicin cream 
Rugby Laboratories

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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 DrugM01702/17/2020
Labeler - Rugby Laboratories (079246066)
Registrant - Trifecta Pharmaceuticals USA LLC (079424163)

Revised: 12/2024
Document Id: 297d6703-ed4d-10d3-e063-6394a90a9f3a
Set id: 9eca34f1-e91a-3ac1-e053-2a95a90a9bd9
Version: 4
Effective Time: 20241217
 
Rugby Laboratories