PAIN RELIEFPATCHES PATCHES- dl-camphor l-menthol methyl salicylate patch

Pain ReliefPatches by

Drug Labeling and Warnings

Pain ReliefPatches by is a Otc medication manufactured, distributed, or labeled by Shanghai Aquagel Bio-Plymer Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

For External Use Only

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

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

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

PURPOSE

Uses

For temporary relief of minor aches and pains associated with:

Arthritis

Backaches

Sprains

Strains

Bruises

WARNINGS

Warnings

For External Use Only

INDICATIONS & USAGE

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

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

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

DOSAGE & ADMINISTRATION

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.

STORAGE AND HANDLING

Other information

Store in a cool dry place. Avoid direct sunlight.

INACTIVE INGREDIENT

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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PAIN RELIEFPATCHES   PATCHES
dl-camphor l-menthol methyl salicylate patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53043-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	1.2 mL  in 100 mL
LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7)	LEVOMENTHOL	4 mL  in 100 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	6.3 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53043-001-01	20 in 1 CARTON
1		24 mL in 1 PATCH

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	10/01/2012

Labeler - Shanghai Aquagel Bio-Plymer Co., Ltd (421199544)

Establishment
Name	Address	ID/FEI	Business Operations
Shanghai Aquagel Bio-Plymer Co., Ltd		421199544	manufacture(53043-001)