SOLSTICE PAIN RELIEVING- camphor, menthol, methyl salicylate patch 
MADISON ONE ACME INC

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 ingredient
Camphor 3.1%
Menthol 6.0%
Methyl salicylate 10.0%

Purpose
External analgesic
External analgesic
External analgesic

Uses
For the temporary relief of minor aches and pains of muscles and joints due to:

Warnings
For external use only

Do not use
on irritated or damaged skin on wounds

Ask a doctor or pharmacist before use if you have
any concerns about using this product

When using this product

Stop use and ask a doctor if

Report any unexpected side effects from the use of this product to the FDA MedWatch Program

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

Directions

Other information

Inactive ingredients hydrogenated poly, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, petroleum, and styrene/isoprene copolymer.

Questions or comments? (888) 221-3496 M-F 9 am to 5 pm

Solstice Pain Relieving Patch
Large

Camphor 3.1%, Menthol 6.0%, Methyl Salicylate 10%

NDC 55614-310-06

6 Patches, Each Patch 5.67 in x 3.62 in (14.4 cm x 9.2 cm)
6ct Box
6ct Box

SOLSTICE PAIN RELIEVING 
camphor, menthol, methyl salicylate patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55614-310
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)3.1 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL6 g  in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
LIQUID PETROLEUM (UNII: 6ZAE7X688J)  
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55614-310-066 in 1 BOX07/29/2019
19 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 finalpart34807/29/2019
Labeler - MADISON ONE ACME INC (096196758)
Establishment
NameAddressID/FEIBusiness Operations
Foshan Aqua Gel Biotech Co., Ltd.,529128763manufacture(55614-310)

Revised: 12/2019
Document Id: 85f98b84-cb10-49bb-9726-718ebf34ae87
Set id: 1388ab3a-c26f-427d-898d-0d88411a5fba
Version: 3
Effective Time: 20191202
 
MADISON ONE ACME INC