EQUATE COOL AND HEAT- menthol, methyl salicylate cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A), METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)

Available from:

Wal-Mart Stores Inc

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Menthol - Topical analgesic Methyl salicylate - Topical analgesic temporarily relieves minor aches and pains of muscles and joints due to: - simple backache - arthritis - bruises - muscle strains - muscle sprains

Authorization status:

OTC monograph not final

Summary of Product characteristics

EQUATE COOL AND HEAT- MENTHOL, METHYL SALICYLATE CREAM
WAL-MART STORES INC
_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._
----------
DRUG FACTS
ACTIVE INGREDIENT
Menthol 10%
Methyl salicylate 30%
PURPOSE
Menthol - Topical analgesic
Methyl salicylate - Topical analgesic
USES
temporarily relieves minor aches and pains of muscles and joints due
to:
simple backache
arthritis
bruises
muscle strains
muscle sprains
WARNINGS
FOR EXTERNAL USE ONLY
WHEN USING THIS PRODUCT
use only as directed
do not get into eyes or on mucous membranes
do not apply to wounds or damaged skin
do not bandage tightly
do not use with a heating pad or apply external heat
STOP USE AND ASK A DOCTOR IF
skin redness or excessive irritation of the skin occurs
condition worsens
symptoms persist for more than 7 days or clear up and occur again
within a few
days
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 and over: apply to affected area not more
than 3 to 4
times daily
children under 12 years: ask a doctor
INACTIVE INGREDIENTS
glyceryl stearate, isoceteth-20, poloxamer, purified water, sodium
lauryl sulfate, sorbitan
monostearate, trolamine
QUESTIONS
Call: 1-888-287-1915
PRINCIPAL DISPLAY PANEL
EQUATE COOL AND HEAT
menthol, methyl salicylate cream
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:49035-470
ROUTE OF ADMINISTRATION
TOPICAL
Wal-Mart Stores Inc
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH STRENGTH
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED
FORM - UNII:L7T10EIP3A)
MENTHOL,
UNSPECIFIED FORM
100 mg
in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID -
UNII:O414PZ4LPZ)
METHYL SALICYLATE
300 mg
in 1 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE