ASSURED - dl-camphor l-menthol methyl salicylate patch 
Zhejiang Bangli Medical Products 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 borneol, mineral oil, polyester, styrene/isopropene/styrene copolymer

Active Ingredients

DL-Camphor 1.2%

L - Menthol 5.7%

Methyl salicylate 6.3%

Purpose

Topical analgesic

Warnings

For external use only

Do Not Use

-on wounds, damaged or irritated skin

-for more than 7 days continuously

-in combination with other external analgesics

-in contact with eye or mucous membranes

-with a heating pad


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


Uses. For temporary relief of minor aches and pains associated with;

-arthritis

-backaches

-sprains

-strains

-bruises

Directions

Adults and children 12 years of age and older: - clean and dry the affected area - place patch on the affected area

for no more than 8 hours at a time, up to 3 times per day and for not more than 7 days continuously

Children under 12 years of age: ask a doctor before use

Other information

store at room temperature 59 - 86F (15-30C). Avoid direct sunlight

copy of label

ASSURED  
dl-camphor l-menthol methyl salicylate patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57900-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)1.2 mg  in 100 mg
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5.7 mg  in 100 mg
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE6.3 mg  in 100 mg
Inactive Ingredients
Ingredient NameStrength
BORNEOL (UNII: M89NIB437X)  
MINERAL OIL (UNII: T5L8T28FGP)  
STYRENE (UNII: 44LJ2U959V)  
ISOPRENE (UNII: 0A62964IBU)  
POLYESTER-10 (UNII: 212N9O2MMZ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57900-001-012000 mg in 1 BOX; Type 0: Not a Combination Product07/01/201309/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/01/201309/01/2016
Labeler - Zhejiang Bangli Medical Products Co., Ltd (421295875)
Establishment
NameAddressID/FEIBusiness Operations
Zhejiang Bangli Medical Products Co., Ltd421295875manufacture(57900-001)

Revised: 9/2016
 
Zhejiang Bangli Medical Products Co., Ltd