PERSONAL CARE EXTRA STRENGTH COLD HOT- menthol patch

PERSONAL CARE EXTRA STRENGTH COLD HOT by

Drug Labeling and Warnings

PERSONAL CARE EXTRA STRENGTH COLD HOT by is a Otc medication manufactured, distributed, or labeled by PERSONAL CARE PRODUCTS, LLC, UNITED EXCHANGE CORP, PLANET (SUZHOU) MEDICAL PRODUCTS CO., LTD, Yongkang Bangli Medical Products Co Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient                                                                    Purpose

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

PURPOSE

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

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

WARNINGS

Warnings

For external use only

WHEN USING

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

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
  

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

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

STORAGE AND HANDLING

Other information

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

INACTIVE INGREDIENT

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).

DOSAGE & ADMINISTRATION

Distributed by:

PERSONAL CARE PRODUCTS, LLC.

Bingham Farms, MI 48025-3463

Made in China

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

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

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)