PERFECT PURITY HOTICE- menthol gel

Perfect Purity HotIce by

Drug Labeling and Warnings

Perfect Purity HotIce by is a Otc medication manufactured, distributed, or labeled by Davion, Inc dba HABA, Anicare Pharmaceuticals Pvt. Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Menthol 1%                                

PURPOSE

Purpose

Topical Analgesic

INDICATIONS & USAGE

Uses

Provides temporary relief of minor aches and pains in muscles and joints associated with simple backache, strains, sprains, arthritis and sports injuries.

WARNINGS

Warnings

For external use only. Not for internal use.

WHEN USING

Use only as directed. Avoid contact with eyes or mucous membranes.  Do not apply to open wounds or damaged skin. Make sure skin is clean and free from any creams, ointments, sprays or liniment. Do not bandage.

Do not use with heating pads or heating devices.

STOP USE

If condition worsens, symptoms persist for more than 7 days or if symptoms disappear and occur again within a few days, discontinue use and consult a physician.  If you are pregnant or nursing a baby, consult your doctor before use

DO NOT USE

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

STORAGE AND HANDLING

Store in a cool, dry place and keep lid tightly closed.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION

Directions

Clean skin of all other lotions, creams, ointments, liniments or sprays.

Apply liberally to affected area and massage until gel is absorbed into the skin.

Do not apply more than 3 or 4 times daily. No protective cover needed. Do not apply to children under 2 years of age.

INACTIVE INGREDIENT

Inactive Ingredients

Water, Isopropyl Alcohol, Nonoxylon-10,  Camphor, Carbomer, Sodium Hydroxide, Methylchloroisothiazolinone, Methylisothiazolinone and Blue 1 (CI 42090).

PRINCIPAL DISPLAY PANEL

Perfect Purity HotIce Gel

Topical Analgesic

Net Wt. 8 OZ (227g)

INGREDIENTS AND APPEARANCE

PERFECT PURITY HOTICE 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42669-998
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1.0 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
NONOXYNOL-10 (UNII: K7O76887AP)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42669-998-02	227 g in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	12/24/2013

Labeler - Davion, Inc dba HABA (174542928)

Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)

Establishment
Name	Address	ID/FEI	Business Operations
Anicare Pharmaceuticals Pvt. Ltd		916837425	manufacture(42669-998)