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NDC 00363-6330-01 Walgreens Ice Blue Pain Relieving 20 mg/g Details

Walgreens Ice Blue Pain Relieving 20 mg/g

Walgreens Ice Blue Pain Relieving is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Walgreen Company. The primary component is MENTHOL, UNSPECIFIED FORM.

Product Information

NDC	00363-6330
Product ID	0363-6330_52ec4298-44ef-4440-b625-8bf16ed11e86
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	Walgreens Ice Blue Pain Relieving
Proprietary Name Suffix	Topical Analgesic
Non-Proprietary Name	MENTHOL, UNSPECIFIED FORM
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	20
Active Ingredient Units	mg/g
Substance Name	MENTHOL, UNSPECIFIED FORM
Labeler Name	Walgreen Company
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 00363-6330-01 (00363633001)

Pricing Information	N/A
NDC Package Code	0363-6330-01
Billing NDC	00363633001
Package	226.8 g in 1 JAR (0363-6330-01)
Marketing Start Date	2015-11-18
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 1c0ee442-ffd2-4f6c-aab2-f70e295378ad Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Menthol 2.0%

Purpose

Topical Analgesic

Uses

♦

temporarily relieves minor aches and pains of muscles and joints associated with

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

Warnings

For external use only

When using this product

♦: do not use with other topical pain relievers
♦: do not use with heating pads or other heating devices
♦: avoid contact with the eyes
♦: do not bandage tightly
♦: do not apply to wounds or damaged skin

Stop use and ask a doctor if

♦: condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

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 immediately at 1-800-222-1222.

Directions

♦: Clean affected area before applying product
♦: adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
♦: children under 2 years of age: do not use, consult a doctor.

Other information

♦: do not freeze
♦: store at room temperature
♦: keep container tightly closed when not in use
♦: do not use, pour, spill or store near heat or open flame

Inactive ingredients

ammonium hydroxide, blue 1, carbomer, copper sulfate, isopropyl alcohol, magnesium sulfate, sodium hydroxide, thymol, water.

Questions or comments?

1-800-925-4733

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

PRINCIPAL DISPLAY PANEL - 226.8 g Jar Label

Walgreens

Compare to Mineral Ice® active ingredient††

Ice Blue Gel

MENTHOL 2.0% / PAIN RELIEVING GEL

COOLING

FAST ACTING

Non-greasy

NET WT 8 OZ (226.8 g)

PRINCIPAL DISPLAY PANEL - 226.8 g Jar Label

INGREDIENTS AND APPEARANCE

WALGREENS ICE BLUE PAIN RELIEVING TOPICAL ANALGESIC

menthol, unspecified form gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-6330
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	20 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
AMMONIA (UNII: 5138Q19F1X)
DISODIUM N-ETHYL-N-4-((4-(ETHYL((3-SULFOPHENYL)METHYL)AMINO)PHENYL)(2-SULFOPHENYL)METHYLENE)-2,5-CYCLOHEXADIEN-1-YLIDENE)-3-SULFOBENZENEMETHANAMINIUM (UNII: PPQ093M8HR)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
CUPRIC SULFATE ANHYDROUS (UNII: KUW2Q3U1VV)
Isopropyl Alcohol (UNII: ND2M416302)
MAGNESIUM SULFATE ANHYDROUS (UNII: ML30MJ2U7I)
Sodium Hydroxide (UNII: 55X04QC32I)
Thymol (UNII: 3J50XA376E)
Water (UNII: 059QF0KO0R)

Product Characteristics
Color	BLUE	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0363-6330-01	226.8 g in 1 JAR; Type 0: Not a Combination Product	11/18/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part348	11/18/2015

Labeler - Walgreen Company (008965063)

Registrant - Garcoa, Inc. (036464697)

Name	Address	ID/FEI	Business Operations
Establishment
Sigan Industries INC		255106239	MANUFACTURE(0363-6330)

Revised: 4/2022

Document Id: 52ec4298-44ef-4440-b625-8bf16ed11e86

Set id: 1c0ee442-ffd2-4f6c-aab2-f70e295378ad

Version: 1

Effective Time: 20220429

Search by Drug Name or NDC

NDC 00363-6330-01 Walgreens Ice Blue Pain Relieving 20 mg/g Details

Walgreens Ice Blue Pain Relieving 20 mg/g

Product Information

Package

Package Images

NDC 00363-6330-01 (00363633001)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 1c0ee442-ffd2-4f6c-aab2-f70e295378ad Details

SPL UNCLASSIFIED SECTION

Active ingredient

Purpose

Uses

Warnings

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 - 226.8 g Jar Label

INGREDIENTS AND APPEARANCE

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