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NDC 41250-0378-01 Meijer Extra Strength Cold And Hot TherapyPain Relieving 100; 300 mg/g; mg/g Details

Meijer Extra Strength Cold And Hot TherapyPain Relieving 100; 300 mg/g; mg/g

Meijer Extra Strength Cold And Hot TherapyPain Relieving is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Meijer Distribution, INC. The primary component is MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE.

Product Information

NDC	41250-0378
Product ID	41250-378_b6c0988e-6f57-45c0-9832-f3278abd2050
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Meijer Extra Strength Cold And Hot TherapyPain Relieving
Proprietary Name Suffix	Topical Analgesic
Non-Proprietary Name	menthol, unspecified form and methyl salicylate
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	100; 300
Active Ingredient Units	mg/g; mg/g
Substance Name	MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE
Labeler Name	Meijer Distribution, INC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2024-12-31

Package

Package Images

NDC 41250-0378-01 (41250037801)

Pricing Information	N/A
NDC Package Code	41250-378-01
Billing NDC	41250037801
Package	1 TUBE in 1 CARTON (41250-378-01) / 35.4 g in 1 TUBE
Marketing Start Date	2020-11-30
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 781f89c0-94ab-48de-9e0b-decb37bcde46 Details

SPL UNCLASSIFIED SECTION

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredients	Purpose
Menthol 10%	Topical analgesic
Methyl Salicylate 30%	Topical analgesic

Uses

temporarily relieves minor pain associated with:

muscle sprains
muscle strains
simple backache
bruises
arthritis

Warnings

For external use only

Test on a small patch before applying generously.

Allergy alert

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

When using this product

use only as directed. Read and follow all directions and warnings on this label
do not bandage tightly or apply local heat (such as heating pads) to the area of use or use with a medicated patch
avoid contact with eyes or mucous membranes
do not apply to wounds or damaged, broken or irritated skin
a transient burning sensation may occur upon application but generally disappears in seven days

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
irritation develops
you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

If pregnant or breastfeeding, ask a health professional before use.

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

Directions

Adults and children over 12 years:

apply to affected area
massage into painful area until thoroughly absorbed into skin
repeat as necessary, but no more than 4 times daily
AFTER APPLYING, WASH HANDS WITH SOAP AND WATER.

Children 12 years or younger: ask a doctor

Other information

Keep tightly closed. Store at room temperature.

Inactive ingredients

acrylates/C10-30 alkyl acrylate crosspolymer, carbomer, ceteareth-20, cetearyl alcohol, oleth-3 phosphate, phenoxyethanol, polysorbate 60, sodium hydroxide, stearic acid, water.

Questions or comments?

1-866-567-8600

SPL UNCLASSIFIED SECTION

DIST. BY MEIJER

DISTRIBUTION, INC.

GRAND RAPIDS, MI 49544

PRINCIPAL DISPLAY PANEL - 35.4 g Tube Carton

Compare to

Icy Hot®Active

Ingredients*

meijer®

EXTRA STRENGTH

cold & hot therapy

Menthol 10% (Topical Anangesic)

Methyl Salicylate 30% (Topical Anangesic)

Pain Relieving Cream

Body & Backache | Bruises | Arthritis | Sore Muscles

NET WT 1.25 OZ (35.4 g)

PRINCIPAL DISPLAY PANEL - 35.4 g Tube Carton

INGREDIENTS AND APPEARANCE

MEIJER EXTRA STRENGTH COLD AND HOT THERAPYPAIN RELIEVING TOPICAL ANALGESIC

menthol, unspecified form and methyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41250-378
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	100 mg in 1 g
Methyl Salicylate (UNII: LAV5U5022Y) (Salicylic Acid - UNII:O414PZ4LPZ)	Methyl Salicylate	300 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
Carbomer Interpolymer Type A (Allyl Sucrose Crosslinked) (UNII: 59TL3WG5CO)
Carbomer Homopolymer, Unspecified Type (UNII: 0A5MM307FC)
Polyoxyl 20 Cetostearyl Ether (UNII: YRC528SWUY)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Oleth-3 Phosphate (UNII: 8Q0Z18J1VL)
Phenoxyethanol (UNII: HIE492ZZ3T)
Polysorbate 60 (UNII: CAL22UVI4M)
Sodium Hydroxide (UNII: 55X04QC32I)
Stearic Acid (UNII: 4ELV7Z65AP)
Water (UNII: 059QF0KO0R)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:41250-378-01	1 in 1 CARTON	11/30/2020
1		35.4 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	11/30/2020

Labeler - Meijer Distribution, INC (006959555)

Registrant - Garcoa, Inc. (036464697)

Name	Address	ID/FEI	Business Operations
Establishment
Sigan Industries INC.		255106239	MANUFACTURE(41250-378)

Revised: 1/2022

Document Id: b6c0988e-6f57-45c0-9832-f3278abd2050

Set id: 781f89c0-94ab-48de-9e0b-decb37bcde46

Version: 2

Effective Time: 20220121

Search by Drug Name or NDC

NDC 41250-0378-01 Meijer Extra Strength Cold And Hot TherapyPain Relieving 100; 300 mg/g; mg/g Details

Meijer Extra Strength Cold And Hot TherapyPain Relieving 100; 300 mg/g; mg/g

Product Information

Package

Package Images

NDC 41250-0378-01 (41250037801)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 781f89c0-94ab-48de-9e0b-decb37bcde46 Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Uses

Warnings

Allergy alert

When using this product

Stop use and ask a doctor if

Directions

Other information

Inactive ingredients

Questions or comments?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 35.4 g Tube Carton

INGREDIENTS AND APPEARANCE

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