RITE AID CAPSICUM HOT - capsaicin patch 
RITE AID CORPORATION

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.

----------

Drug Facts

Active ingredient                                                                                                     Purpose

Capsicum extract 0.025% as Capsaicin....................................................................Topical analgesic

Uses

Temporarily relieves minor pain associated with:

Warnings

If pregnant or breastfeeding

consult a healthcare professional before use.

Do not use

When using this product

Stop use and ask a doctor if

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

Directions

adults and children 12 years of age and older

children under 12 years of age consult a doctor

Other information

Inactive ingredients

BHT, Isopropyl myristate, Natural rubber, Polybutene, Polyisobutylene, Precipitated calcium carbonate, Propylene carbonate, Quinton, Sorbitan monostearate, Titanium oxide, YS resin, Zinc oxide

DISTRIBUTED BY:

RITE AID, 30 HUNTER LANE

CAMP HILL, PA 17011

MADE IN KOREA

image of carton label

RITE AID CAPSICUM HOT 
capsaicin patch
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-5744
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN 0.6 mg
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)  
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:11822-5744-3 3 in 1 POUCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 11/30/2012
Labeler - RITE AID CORPORATION (014578892)

Revised: 11/2012
Document Id: 3953ad5a-6712-4377-9af0-2a6358790909
Set id: 9ff7fa60-d0b4-401d-b056-dd503a481761
Version: 1
Effective Time: 20121130
 
RITE AID CORPORATION