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NDC 43749-0321-08 Avedana Cool Hot Ice 2 g/100g Details

Avedana Cool Hot Ice 2 g/100g

Avedana Cool Hot Ice is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Unipack, Inc.. The primary component is MENTHOL.

Product Information

NDC	43749-0321
Product ID	43749-321_1850af06-be68-45cd-a107-604506bef374
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	Avedana Cool Hot Ice
Proprietary Name Suffix	n/a
Non-Proprietary Name	Menthol
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	2
Active Ingredient Units	g/100g
Substance Name	MENTHOL
Labeler Name	Unipack, 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 43749-0321-08 (43749032108)

Pricing Information	N/A
NDC Package Code	43749-321-08
Billing NDC	43749032108
Package	227 g in 1 JAR (43749-321-08)
Marketing Start Date	2017-11-04
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 619c8e3f-0cad-4eb1-8dbb-632f3db74ba3 Details

Active Ingredient

Active Ingredients Purpose

Menthol 2%..................................................External Pain Reliever

Purpose

External Pain Reliever

Uses

Temporarily relief of minor pains of muscles and joints associated with - simple back ache - arthritis - sprains, strains, or bruises

Warnings

For external use only. Avoid contact with eyes

Do not use

Do not use - internally - with heating pad or devices - on wounds or damaged skin

Ask a doctor before use

Ask doctor before use if you have sensitive skin

When using this product

When using this product - Use only as directed - do not bandage tightly - avoid contact with eyes and mucus membranes

If pregnant or breast-feeding

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children

Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Directions

-Adult and children 2 years of age and older. Clean skin thoroughly. Apply liberally to affected area no more than 3-4 times daily. No protective cover needed.

-May be used with ice packs

-May be used with wet or dry bandages, but wrap loosely

-Children under 2 years of age, consult a doctor

Other information

Other information store between 59o - 86oF (15o - 30oC)

Keep tightly closed

Do not use, pour, spill, or store near heat or open flame

Other ingredients

Camphor, Carbomer 940, FDC Blue #1, Isopropyl alcohol, Propylene glycol, Purified water, Sodium hydroxide

Product Label

INGREDIENTS AND APPEARANCE

AVEDANA COOL HOT ICE

menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43749-321
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	2 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
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:43749-321-08	227 g in 1 JAR; Type 0: Not a Combination Product	11/04/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	11/04/2017

Labeler - Unipack, Inc. (009248480)

Name	Address	ID/FEI	Business Operations
Establishment
Unipack, Inc.		009248480	manufacture(43749-321)

Revised: 5/2018

Document Id: 1850af06-be68-45cd-a107-604506bef374

Set id: 619c8e3f-0cad-4eb1-8dbb-632f3db74ba3

Version: 2

Effective Time: 20180501