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NDC 41250-0350-01 Meijer Maximum Strength Pain Relieving 160 mg/mL Details

Meijer Maximum Strength Pain Relieving 160 mg/mL

Meijer Maximum Strength Pain Relieving is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Meijer Distribution, INC. The primary component is MENTHOL, UNSPECIFIED FORM.

Product Information

NDC	41250-0350
Product ID	41250-350_053f640b-b258-479e-ac94-60229d14b2eb
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 Maximum Strength Pain Relieving
Proprietary Name Suffix	Analgesic
Non-Proprietary Name	menthol, unspecified form
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	160
Active Ingredient Units	mg/mL
Substance Name	MENTHOL, UNSPECIFIED FORM
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 41250-0350-01 (41250035001)

Pricing Information	N/A
NDC Package Code	41250-350-01
Billing NDC	41250035001
Package	1 BOTTLE, WITH APPLICATOR in 1 CARTON (41250-350-01) / 74 mL in 1 BOTTLE, WITH APPLICATOR
Marketing Start Date	2019-02-24
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL bd6f04f9-a23b-45f6-bce2-1ef7203198e1 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Menthol 16%

Purpose

Topical analgesic

Uses

for the temporary relief of minor aches and pains of muscles and joints associated with:

♦: simple backache
♦: arthritis
♦: strains
♦: bruises
♦: sprains

Warnings

For external use only. Test on a small patch of skin before applying generously.

When using this product

♦: use only as directed
♦: avoid contact with the eyes and mucous membranes
♦: do not apply to wounds or damaged skin
♦: do not bandage tightly
♦: do not use with heating pads or other heating devices
♦: if redness is present, discontinue use and consult a doctor
♦: if skin irritation occurs, discontinue use
♦: a transient burning sensation may occur upon application but generally disappears in several days

Stop use and consult a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.

Flammable

♦: keep away from fire or flame

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 immediately.

Directions

adults and children 12 years of age and older:

♦: apply generously to affected area
♦: massage into painful area until thoroughly absorbed into skin
♦: repeat if necessary, but not more than 3 to 4 times daily
♦: IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER.

Children 12 years or younger: ask a doctor

Other information

store at room temperature

Inactive ingredients

acrylates/C10-30 alkyl acrylate crosspolymer, alcohol denat., capsaicin, citric acid, glycerin, isopropyl myristate, propylene glycol, water.

Questions or comments?

1-866-567-8600

SPL UNCLASSIFIED SECTION

DIST. BY MEIJER DISTRIBUTION, INC.

GRAND RAPIDS, MI 49544

PRINCIPAL DISPLAY PANEL - 74 mL Bottle Carton

meijer®

Compare to

Icy Hot® Active

Ingredient*

MAXIMUM

STRENGTH

cold

& hot

Pain Relieving Liquid

Menthol 16%

STAIN

FREE

No-Mess Applicator

Keeps Hands Clean

Powerful, Fast and

Effective Pain Relief

2.5 FL OZ (74mL)

PRINCIPAL DISPLAY PANEL - 74 mL Bottle Carton

INGREDIENTS AND APPEARANCE

MEIJER MAXIMUM STRENGTH PAIN RELIEVING ANALGESIC

menthol, unspecified form liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41250-350
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	160 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
Carbomer Interpolymer Type A (Allyl Sucrose Crosslinked) (UNII: 59TL3WG5CO)
Alcohol (UNII: 3K9958V90M)
Capsaicin (UNII: S07O44R1ZM)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Glycerin (UNII: PDC6A3C0OX)
Isopropyl Myristate (UNII: 0RE8K4LNJS)
Propylene Glycol (UNII: 6DC9Q167V3)
Water (UNII: 059QF0KO0R)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:41250-350-01	1 in 1 CARTON	02/24/2019
1		74 mL in 1 BOTTLE, WITH APPLICATOR; 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	02/24/2019

Labeler - Meijer Distribution, INC (006959555)

Registrant - Garcoa, Inc. (036464697)

Name	Address	ID/FEI	Business Operations
Establishment
Sigan Industries INC.		255106239	MANUFACTURE(41250-350)

Revised: 1/2022

Document Id: 053f640b-b258-479e-ac94-60229d14b2eb

Set id: bd6f04f9-a23b-45f6-bce2-1ef7203198e1

Version: 2

Effective Time: 20220118

Search by Drug Name or NDC

NDC 41250-0350-01 Meijer Maximum Strength Pain Relieving 160 mg/mL Details

Meijer Maximum Strength Pain Relieving 160 mg/mL

Product Information

Package

Package Images

NDC 41250-0350-01 (41250035001)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL bd6f04f9-a23b-45f6-bce2-1ef7203198e1 Details

SPL UNCLASSIFIED SECTION

Active ingredients

Purpose

Uses

Warnings

When using this product

Flammable

Directions

Other information

Inactive ingredients

Questions or comments?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 74 mL Bottle Carton

INGREDIENTS AND APPEARANCE

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