CARE ONE COOL HEAT PAIN RELIEVING- menthol, methyl salicylate cream

CARE ONE COOL HEAT PAIN RELIEVING by

Drug Labeling and Warnings

CARE ONE COOL HEAT PAIN RELIEVING by is a Otc medication manufactured, distributed, or labeled by AMERICAN SALES COMPANY. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients                                                                                     Purpose

Menthol 10%............................................................................................Topical Analgesic

Methyl Salicylate 30%...............................................................................Topical Analgesic

PURPOSE

Uses

temporarily relieves minor pain associated with

• Arthritis
• Simple backache
• Muscle strains
• Sprains
• Bruises
• Cramps
  

WARNINGS

Warning

For external use only

Allergy alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

WHEN USING

When using this product

• Use only as directed
• Do not bandage tightly or sue with a heating pad
• Avoid contact with eyes or mucous membranes
• Do not apply to wounds, damaged, broken or irritated skin
  

STOP USE

Stop use and ask a doctor if

• condition worsens
• symptoms persist for more than 7 days or clear up and occur again within a few days
• redness is present
• 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.  In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

Directions Adults and children over 12 years

• apply generously to affected area
• massage into painful area until thoroughly absorbed into skin
• repeat as necessary but no more than 4 times daily
• close cap tightly after use
• keep carton as it contains important information

Children 12 years or younger: Ask a doctor

INACTIVE INGREDIENT

Inactive ingredients

Carbomer, Cetyl Esters, Emulsifying Wax, Oleth-3 phosphate, Stearic Acid, Triethanolamine, Water

DOSAGE & ADMINISTRATION

DISTRIBUTED BY: AMERICAN SALES COMPANY

4201 WALDEN AVENUE, LANCASTER, NY 14086

www.care1.info

Made in Korea

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

CARE ONE COOL HEAT PAIN RELIEVING 
menthol, methyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41520-863
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10 g  in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y)	METHYL SALICYLATE	30 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CETYL ESTERS WAX (UNII: D072FFP9GU)
OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)
STEARIC ACID (UNII: 4ELV7Z65AP)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41520-863-35	1 in 1 CARTON
1		35 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/01/2012

Labeler - AMERICAN SALES COMPANY (809183973)