MINI PAIN RELIEF - dl-camphor l-menthol methyl salicylate patch 
Shanghai Aquagel Bio-Plymer Co., Ltd

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

Inactive ingredients Ammonium Stearate, Calcium Carbonate, Glyceryl Abietate, Isopropyl Myristate, Natural
Rubber,Polybutene, Polyisobutylene, Propylene Carbonate, Styrene Copolymer, YS Resin, Zinc Oxide

Active ingredients

DL-Camphor 1.2%

L-Menthol 2,.%

Methyl Salicylate 2.5%

Purpose

Topical Analgesic

Keep out of reach of children. If swallowed, get medical help or contact a poison control center immediately

Do not use

other than as directed on wounds, damaged or irritated skin in combination with other
external analgesic products, ointments, creams or with a heating pad. in contact with eyes or mucous
membranes. if you are allergic to any ingredient in this product or if you have a history of allergic reactions to this
or similar products

Stop Use and ask a
doctor if


rash, itching or excessive skin irritation develops

condition worsens

symptoms persist for more
than 7 days

if symptoms
subside and then reappear within a few days.

Warnings

For External Use Only

Directions

Adults and children 12 years of age and over: Clean and dry the affected area. Remove
patch from film backing. Adhere to area for no more than 8 hours at a time, not more than 3 times per day, and for no more
than 7 days continuously. Children under 12 years of age: Consult a doctor before use.

Uses

For temporary relief of minor aches and pains associated with:

Arthritis

Backaches

Sprains

Strains

Bruises

copy of label

MINI PAIN RELIEF 
dl-camphor l-menthol methyl salicylate patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53043-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)1.2 mg
LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL2.7 mg
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE2.5 mg
Inactive Ingredients
Ingredient NameStrength
AMMONIUM STEARATE (UNII: 37899330TZ)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
GLYCERYL ABIETATE (UNII: 2F22LY70Q1)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)  
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)  
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
STYRENE (UNII: 44LJ2U959V)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53043-003-0120 in 1 CARTON
2NDC:53043-003-0220 in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/01/2012
Labeler - Shanghai Aquagel Bio-Plymer Co., Ltd (421199544)
Establishment
NameAddressID/FEIBusiness Operations
Shanghai Aquagel Bio-Plymer Co., Ltd421199544manufacture(53043-003, 53043-003)

Revised: 12/2012
Document Id: 8dccfbae-5bf0-4c02-8c03-da491358efa7
Set id: e1aae2c4-172f-4c73-9326-227828089360
Version: 7
Effective Time: 20121226
 
Shanghai Aquagel Bio-Plymer Co., Ltd