PAIN RELIEFPATCHES  PATCHES- 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.

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Drug Facts

Active ingredients

For External Use Only

DL-Camphor 1.2%.......................................................................................................................................Topical analgesic

L-Menthol 4.0%..........................................................................................................................................Topical analgesic

Methyl Salicylate 6.3%................................................................................................................................Topical analgesic

Uses

For temporary relief of minor aches and pains associated with:

Arthritis

Backaches

Sprains

Strains

Bruises

Warnings

For External Use Only

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. 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.

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

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.

Other information

Store in a cool dry place. Avoid direct sunlight.

Inactive ingredients Ammonium Stearate, Calcium Carbonate, Glyceryl Abietate, Isopropyl Myristate, Natural

Rubber, Polybutene, Polyisobutylene, Propylene Carbonate, Styrene Copolymer, YS Resin, Zinc Oxide

image of label

PAIN RELIEFPATCHES   PATCHES
dl-camphor l-menthol methyl salicylate patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53043-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)1.2 mL  in 100 mL
LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL4 mL  in 100 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE6.3 mL  in 100 mL
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:53043-001-0120 in 1 CARTON
124 mL in 1 PATCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/01/2012
Labeler - Shanghai Aquagel Bio-Plymer Co., Ltd (421199544)
Establishment
NameAddressID/FEIBusiness Operations
Shanghai Aquagel Bio-Plymer Co., Ltd421199544manufacture(53043-001)

Revised: 8/2012
Document Id: 56d787bf-d7c2-463b-aac7-b00dcfdb2230
Set id: acba6dff-c4c4-46e7-9ae4-f06e8fe60afc
Version: 1
Effective Time: 20120815
 
Shanghai Aquagel Bio-Plymer Co., Ltd