Your browser does not support JavaScript! PERSONAL CARE EXTRA STRENGTH COLD HOT (MENTHOL) PATCH [PERSONAL CARE PRODUCTS, LLC]
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PERSONAL CARE EXTRA STRENGTH COLD HOT (menthol) patch
[PERSONAL CARE PRODUCTS, LLC]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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 Label Sections

Active ingredient                                                                    Purpose

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

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

  • simple backache
  • muscle strains
  • muscle sprains
  • cramps
  • bursitis
  • arthritis
  • bruises

Warnings

For external use only


When using this product

  • use only as directed
  • do not apply to wounds, damaged, or sensitive skin
  • do not bandage tightly or use with a heating pad
  • avoid contact with eyes and mucous membranes

Stop use and ask doctor if

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days
  • redness is present
  • skin irritation develops

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

  • partially peel back protective film and apply exposed patch to site of pain
  • carefully remove remaining film while pressing patch to skin for secure adhesion
  • repeat as necessary, but not more than 3 to 4 times daily
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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:29500-9083
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL50 mg
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
ALUMINUM HYDROXIDE 
BUTYLATED HYDROXYTOLUENE 
CASTOR OIL 
EDETATE DISODIUM 
GELATIN 
GLYCERIN 
ISOPROPYL MYRISTATE 
KAOLIN 
METHYLPARABEN 
POLYSORBATE 80 
POLYVINYL ALCOHOL 
WATER 
MAGNESIUM ALUMINOMETASILICATE TYPE I-A 
PEG-120 Stearate 
povidone K90 
sodium polyacrylate (2500000 MW) 
tartaric acid 
titanium dioxide 
.alpha.-tocopherol acetate 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:29500-9083-31 in 1 CARTON
12 in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/20/2011
Labeler - PERSONAL CARE PRODUCTS, LLC (966155082)
Registrant - UNITED EXCHANGE CORP (840130579)
Establishment
NameAddressID/FEIBusiness Operations
PLANET (SUZHOU) MEDICAL PRODUCTS CO., LTD528194366manufacture(29500-9083)
Establishment
NameAddressID/FEIBusiness Operations
Yongkang Bangli Medical Products Co Ltd723738741manufacture(29500-9083)

Revised: 9/2012
 
PERSONAL CARE PRODUCTS, LLC

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