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NDC 41163-0692-85 Equaline cool heat 10; 30 g/100g; g/100g Details

Equaline cool heat 10; 30 g/100g; g/100g

Equaline cool heat is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Supervalu Inc. The primary component is MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE.

Product Information

NDC	41163-0692
Product ID	41163-692_0b15ad5a-8c0a-466e-8562-b36b41c2b2d4
Associated GPIs	90809902603700
GCN Sequence Number	061387
GCN Sequence Number Description	methyl salicylate/menthol CREAM (G) 30 %-10 % TOPICAL
HIC3	L6A
HIC3 Description	IRRITANTS/COUNTER-IRRITANTS
GCN	97179
HICL Sequence Number	002583
HICL Sequence Number Description	METHYL SALICYLATE/MENTHOL
Brand/Generic	Generic
Proprietary Name	Equaline cool heat
Proprietary Name Suffix	n/a
Non-Proprietary Name	Menthol, Methyl salicylate
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	10; 30
Active Ingredient Units	g/100g; g/100g
Substance Name	MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE
Labeler Name	Supervalu Inc
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2023-12-31

Package

Package Images

NDC 41163-0692-85 (41163069285)

Pricing Information	N/A
NDC Package Code	41163-692-85
Billing NDC	41163069285
Package	1 TUBE in 1 CARTON (41163-692-85) / 35 g in 1 TUBE
Marketing Start Date	2010-03-30
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 4e9ddf4d-5036-46bf-b542-621b7bcaaa2d Details

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)

INGREDIENTS AND APPEARANCE

EQUALINE COOL HEAT

menthol, methyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41163-692
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	10 g in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	30 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:41163-692-85	1 in 1 CARTON	03/30/2010
1		35 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	03/30/2010

Labeler - Supervalu Inc (006961411)

Revised: 12/2019

Document Id: 0b15ad5a-8c0a-466e-8562-b36b41c2b2d4

Set id: 4e9ddf4d-5036-46bf-b542-621b7bcaaa2d

Version: 4

Effective Time: 20191211