MEIJER EXTRA STRENGTH COLD AND HOT THERAPYPAIN RELIEVING TOPICAL ANALGESIC- menthol, unspecified form and methyl salicylate crea

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Menthol, Unspecified Form (UNII: L7T10EIP3A) (Menthol, Unspecified Form - UNII:L7T10EIP3A), Methyl Salicylate (UNII: LAV5U5022Y) (Salicylic Acid - UNII:O414PZ4LPZ)
Available from:
Meijer Distribution, INC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
temporarily relieves minor pain associated with: - muscle sprains - muscle strains - simple backache - bruises - arthritis
Authorization status:
OTC monograph not final
Authorization number:
41250-378-01

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MEIJER EXTRA STRENGTH COLD AND HOT THERAPYPAIN RELIEVING TOPICAL

ANALGESIC- menthol, unspecified form and methyl salicylate cream

Meijer Distribution, 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.

----------

Meijer

Extra Strength Cold & Hot TherapyPain Relieving Cream

Topical Analgesic

Drug Facts

Active ingredients

Purpose

Menthol 10%

Topical analgesic

Methyl Salicylate 30%

Topical analgesic

Us es

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

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)

MEIJER EXTRA STRENGTH COLD AND HOT THERAPYPAIN RELIEVING

TOPICAL ANALGESIC

menthol, unspecified form and methyl salicylate cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:41250 -378

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Mentho l, Unspecified Fo rm (UNII: L7T10 EIP3A) (Mentho l, Unspecified Fo rm -

UNII:L7T10 EIP3A)

Mentho l, Unspecified

Fo rm

10 0 mg

in 1 g

Methyl Sa licyla te (UNII: LAV5U50 22Y) (Salicylic Acid - UNII:O414PZ4LPZ)

Methyl Salicylate

30 0 mg

in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

Ca rbo mer Interpo lymer Type A ( Allyl Sucro se Cro sslinked) (UNII: 59 TL3WG5CO)

Ca rbo mer Ho mo po lymer, Unspecified Type (UNII: 0 A5MM30 7FC)

Po lyo xyl 2 0 Ceto stea ryl Ether (UNII: YRC528 SWUY)

Ceto stea ryl Alco ho l (UNII: 2DMT128 M1S)

O leth-3 Pho spha te (UNII: 8 Q0 Z18 J1VL)

Pheno xyetha no l (UNII: HIE49 2ZZ3T)

Po lyso rba te 6 0 (UNII: CAL22UVI4M)

So dium Hydro xide (UNII: 55X0 4QC32I)

Stea ric Acid (UNII: 4ELV7Z6 5AP)

Wa ter (UNII: 0 59 QF0 KO0 R)

Product Characteristics

Color

WHITE

S core

S hap e

S iz e

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:41250 -378 -0 1

1 in 1 CARTON

11/30 /20 20

1

35.4 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH NOT FINAL part348

11/30 /20 20

Labeler -

Meijer Distribution, INC (006959555)

Registrant -

Garcoa, Inc. (036464697)

Meijer Distribution, INC

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Sigan Industries INC.

25510 6 239

MANUFACTURE(41250 -378 )

Revised: 12/2020

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