EQUALINE COOL HEAT- menthol, methyl salicylate cream 
Supervalu 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.

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SuperValu Inc. Cool Heat Pain Relieving Cream Drug Facts

Active ingredients

Menthol 10%

Methyl salicylate 30%

Purpose

Topical analgesic

Uses

temporarily relieves minor pain associated with

arthritis
simple backache
strains
sprains
bruises

Warnings

For external use only

When using this product

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

Stop use and ask a doctor if

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

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

adults and children over 12 years

apply generously to affected area
massage into painful area until thoroughly absorbed into skin
repeat as necessary, not more than 3 to 4 times daily

children 12 years or younger ask a doctor

Other information

store at 20°-25°C (68°-77°F)

Inactive ingredients

carbomer homopolymer, cetyl esters wax, emulsifying wax, oleth-3 phosphate, purified water, stearic acid, trolamine

Questions or comments?

1-877-932-7948

Principal Display Panel

cold & hot therapy for pain

goes on cool to dull the pain

fast relief from arthritis, backache, body aches & sore muscles

compare to Icy Hot® active ingredients

extra strength

cool heat pain relieving cream

NET WT 1.25 OZ (35 g)

Equaline Cool Heat Image
EQUALINE COOL HEAT 
menthol, methyl salicylate cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:41163-692
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) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 30 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
CETYL ESTERS WAX (UNII: D072FFP9GU)  
OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)  
WATER (UNII: 059QF0KO0R)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TROLAMINE (UNII: 9O3K93S3TK)  
Product Characteristics
Color WHITE Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:41163-692-85 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 03/30/2010
Labeler - Supervalu Inc (006961411)

Revised: 10/2014
Document Id: 628cd685-d190-4937-9fd4-224621ef8860
Set id: 4e9ddf4d-5036-46bf-b542-621b7bcaaa2d
Version: 3
Effective Time: 20141031
 
Supervalu Inc