THE BLACK PATCH- menthol patch 
Carbon Innovation, 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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THE BLACK PATCH

Drug Facts

Active ingredient (in each patch)

Menthol 4%

Purpose

Topical analgesic

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

Warnings

For external use only

When using this product

Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

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

Directions

Inactive ingredients

activated charcoal, disodium EDTA, ethanol, gelatin, glycerin, polysorbate 80, polyvinyl alcohol, salt, sodium polyacrylate, tartaric acid, water

Questions or Comments?

1-800-254-5041

HYDROGEL PAIN RELIEF PATCH with MENTHOL

Direction1

Care Instructions

Manufactured by

Carbon Innovation

600 Business Park Dr

Lincoln, CA 95648

Packaging

TBlkPtch

THE BLACK PATCH 
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71948-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
ALCOHOL (UNII: 3K9958V90M)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POLYVINYL ALCOHOL/POLYVINYL ACETATE COPOLYMER (8:1; 50000 MW) (UNII: 8K8B5SD7ZR)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
TARTARIC ACID (UNII: W4888I119H)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Colorblack, white (black and white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71948-101-055 in 1 PACKAGE12/30/2017
10.348 g in 1 PATCH; Type 0: Not a Combination Product
2NDC:71948-101-1010 in 1 BOX12/30/2017
25 in 1 PACKAGE
20.348 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 finalpart34812/30/2017
Labeler - Carbon Innovation, Inc. (080987228)
Establishment
NameAddressID/FEIBusiness Operations
Carbon Innovation, Inc.080987228manufacture(71948-101)

Revised: 12/2017
Document Id: 2a300779-8adc-4113-834f-bcf43277a6f2
Set id: dbf955f7-6d97-45d6-b21d-aa16f0baef8e
Version: 1
Effective Time: 20171222
 
Carbon Innovation, Inc.