COOL N HEAT PATCH FOR BACK EXTRA STRENGTH- menthol patch

Cool n Heat Patch for Back by

Drug Labeling and Warnings

Cool n Heat Patch for Back by is a Otc medication manufactured, distributed, or labeled by Walgreen Co.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Menthol 5%

PURPOSE

Purpose

Topical Analgesic

INDICATIONS & USAGE

Uses

Temporarily relieves minor pain associated with:

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

WARNINGS

Warnings

• For external use only
• If pregnant or breast-feeding, ask a health professional before use.
  

WHEN USING

When using this product

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

STOP USE

Stop use and ask a doctor if

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

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.

DOSAGE & ADMINISTRATION

Directions

adults and children 12 years of age and older

• peel off protective backing and apply sticky side to affected area
• carefully remove backing from patch
• apply one patch to affected area
• repeat as necessary, but no more than 4 times daily

Children under 12 years of age consult a doctor

STORAGE AND HANDLING

Other information

• store at room temperature
  

INACTIVE INGREDIENT

Inactive ingredients

aloe barbadensis leaf juice, alumina magnesium metasilicate, aluminum hydroxide, BHT, castor oil, disodium EDTA, gelatin, glycerin, isopropyl myristate, kaolin, methylparaben, PEG-4 stearate, polysorbate 80, polyvinyl alcohol, purified water, PVP, sodium polyacrylate, tartaric acid, titanium dioxide, tocopherol acetate

QUESTIONS

Questions or comments?

1-800-WALGREENS (1-800-925-4733)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

COOL N HEAT PATCH FOR BACK  EXTRA STRENGTH
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-0152
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A)	Menthol	.05 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Aloe Vera Leaf (UNII: ZY81Z83H0X)
Aluminum Hydroxide (UNII: 5QB0T2IUN0)
Edetate Disodium (UNII: 7FLD91C86K)
Gelatin (UNII: 2G86QN327L)
Kaolin (UNII: 24H4NWX5CO)
Methylparaben (UNII: A2I8C7HI9T)
Glycerin (UNII: PDC6A3C0OX)
Titanium Dioxide (UNII: 15FIX9V2JP)
Isopropyl Myristate (UNII: 0RE8K4LNJS)
Water (UNII: 059QF0KO0R)
PEG-4 Stearate (UNII: J33E8608YN)
Polyvinyl Alcohol (UNII: 532B59J990)
Polysorbate 80 (UNII: 6OZP39ZG8H)
Alpha-Tocopherol Acetate (UNII: 9E8X80D2L0)
Silodrate (UNII: 9T3UU8T0QK)
Castor Oil (UNII: D5340Y2I9G)
Tartaric Acid (UNII: W4888I119H)
Butylated Hydroxytoluene (UNII: 1P9D0Z171K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-0152-01	5 in 1 BOX
1		1 g in 1 PATCH
2	NDC: 0363-0152-02	3 in 1 BOX
2		1 g in 1 PATCH

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	08/15/2013

Labeler - Walgreen Co. (008965063)