AVEDANA COOL HOT ICE- menthol gel

Avedana Cool Hot Ice by

Drug Labeling and Warnings

Avedana Cool Hot Ice by is a Otc medication manufactured, distributed, or labeled by Unipack, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

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

Inactive Ingredients
Ingredient Name	Strength
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43749-321-08	227 g in 1 JAR; Type 0: Not a Combination Product	11/04/2017

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

Labeler - Unipack, Inc. (009248480)

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