TOPCARE HEALTH PAIN RELIEF- menthol, camphor, and methyl salicylate patch 
Topco Associates LLC

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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Active ingredients Purposes

Camphor 1.2%.......................................Topical analgesic

Menthol 5.7%.........................................Topical analgesic

Methyl salicylate 6.3%............................Topical analgesic

Uses

Warnings

For external use only

Allergy alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

Do not use

Ask a doctor before use if you have redness over the affected area.

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

Other information

Inactive ingredients

glyceryl rosinate, lanolin, natural latex rubber, petrolatum, polyisobutylene, zinc oxide

Distributed by:

Topco Associates LLC

Elk Grove IL 60007

Made in China

15679A

TOPCARE HEALTH PAIN RELIEF 
menthol, camphor, and methyl salicylate patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-670
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)0.012 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.057 mg  in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE0.063 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
GLYCERYL ROSINATE (UNII: SD112V492J)  
NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)  
PETROLATUM (UNII: 4T6H12BN9U)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)  
LANOLIN (UNII: 7EV65EAW6H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-670-4040 in 1 CARTON03/08/2022
11 g in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/08/2022
Labeler - Topco Associates LLC (006935977)

Revised: 7/2022
Document Id: e31769bf-c362-6867-e053-2a95a90aebf1
Set id: dac364ef-6dcd-3fc6-e053-2a95a90a9bb2
Version: 3
Effective Time: 20220705
 
Topco Associates LLC