PERFECT PURITY HOTICE- menthol gel 
Davion, Inc dba HABA

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Perfect Purity HotIce Gel

Active Ingredient

Menthol 1%                                

Purpose

Topical Analgesic

Uses

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

Warnings

For external use only. Not for internal use.

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.

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, store, pour, spill near heat or open flame.

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

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

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 Ingredients

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

Perfect Purity HotIce Gel

Topical Analgesic

Net Wt. 8 OZ (227g)

image of front label

PERFECT PURITY HOTICE 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42669-998
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42669-998-02227 g in 1 BOTTLE; Type 0: Not a Combination Product02/02/202208/01/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/24/201308/01/2023
Labeler - Davion, Inc dba HABA (174542928)
Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
Establishment
NameAddressID/FEIBusiness Operations
Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(42669-998)

Revised: 8/2023
 
Davion, Inc dba HABA