PERSONAL CARE EXTRA STRENGTH COLD HOT - menthol patch 
PERSONAL CARE PRODUCTS, 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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Drug Facts

Active ingredient                                                                    Purpose

Menthol 5% ..........................................................................Topical analgesic

Uses for the temporary relief of minor aches and pains associated with:

Warnings

For external use only


When using this product

Stop use and ask 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 right away

Directions

adults and children 12 years of age and older

children under 12 years of age consult a doctor

Other information

Store at 68o to 77oF (20o to 25oC)

Inactive ingredients

aloe vera, aluminum hydroxide, BHT, castor oil, disodium edetate, gelatin, glycerin, isopropyl myristate, kaolin, magnesium aluminometasilicate, methylparaben, polyethylene glycol monsterarate, polysorbate 80,

polyvinyl alcohol, polyvinyl pyrrolidone, purified water, sodium polyacrylate, tartaric acid, titanium dioxide, tocopherol acetate (Vitamin E).

Distributed by:

PERSONAL CARE PRODUCTS, LLC.

Bingham Farms, MI 48025-3463

Made in China

image of carton labelEnter section text here

PERSONAL CARE EXTRA STRENGTH COLD HOT  
menthol patch
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:29500-9083
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 50 mg
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CASTOR OIL (UNII: D5340Y2I9G)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
KAOLIN (UNII: 24H4NWX5CO)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
WATER (UNII: 059QF0KO0R)  
MAGNESIUM ALUMINOMETASILICATE TYPE I-A (UNII: 7LVU907546)  
PEG-120 Stearate (UNII: 0V73PIX5YC)  
povidone K90 (UNII: RDH86HJV5Z)  
sodium polyacrylate (2500000 MW) (UNII: 05I15JNI2J)  
tartaric acid (UNII: W4888I119H)  
titanium dioxide (UNII: 15FIX9V2JP)  
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:29500-9083-3 1 in 1 CARTON
1 2 in 1 POUCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 09/20/2011
Labeler - PERSONAL CARE PRODUCTS, LLC (966155082)
Registrant - UNITED EXCHANGE CORP (840130579)
Establishment
Name Address ID/FEI Business Operations
PLANET (SUZHOU) MEDICAL PRODUCTS CO., LTD 528194366 manufacture(29500-9083)
Establishment
Name Address ID/FEI Business Operations
Yongkang Bangli Medical Products Co Ltd 723738741 manufacture(29500-9083)

Revised: 9/2012
Document Id: a5d0297b-7c72-40df-a650-2eca0117dab2
Set id: 9c16d3be-61d3-489e-8d29-af0c9b8b9165
Version: 6
Effective Time: 20120928
 
PERSONAL CARE PRODUCTS, LLC