FROZEN ICE FAST PAIN RELIEF (menthol camphor- natural gel

FROZEN ICE FAST PAIN RELIEF by

Drug Labeling and Warnings

FROZEN ICE FAST PAIN RELIEF by is a Otc medication manufactured, distributed, or labeled by GADAL Laboratories, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients	Purpose
Menthol 3.5%	Topical Analgesic
Camphor 0.2%	Topical Analgesic

INACTIVE INGREDIENT

Carbomer, Propylene Glycol, Methylparaben, Isopropyl Alcohol, Triethanolamine, FD&C Blue #1, Purified Water.

KEEP OUT OF REACH OF CHILDREN

KEEP THIS AND ALL MEDICINE OUT OF REACH OF CHILDREN

WARNINGS

For the external use only. Use only as directed.

• If condition worsens, or if symptoms persist for more than 7 days or clear up and occurs again within a few days, discontinue use of this product and consults a doctor.
• Avoid contact with eyes.
• Do not use with other topical products.
• Do not use with heating device.
• Do not apply to open wounds or damaged skin.

In case of accidental ingestion, seek professional help and contact a Poison Control Center immediately.

INDICATIONS & USAGE

For temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, sprains.

DOSAGE & ADMINISTRATION

Adults and children 12 years of age and older.
Apply to painful muscles and joints.
Gently massage thoroughly into affected area.
Repeat as necessary but no more than 4 times daily

PURPOSE

Topical Analgesic

Other Information:

Store in cool, dry location at room temperature 59°- 86°F (15° - 30°C) with cao closed tightly. Keep away from excessive heat or open flame.

Manufactured by:

GABAL Laboratories, Inc.

Miami, FL 33186 – (305)382-3288

www.gadallaboratories.com

MADE IN USA

FROZEN ICE FAST PAIN RELIEF

INGREDIENTS AND APPEARANCE

FROZEN ICE FAST PAIN RELIEF 
menthol camphor (natural) gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53113-363
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	3.5 g  in 100 mL
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	0.2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
METHYLPARABEN (UNII: A2I8C7HI9T)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
TROLAMINE (UNII: 9O3K93S3TK)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53113-363-03	89 mL in 1 APPLICATOR; Type 0: Not a Combination Product	11/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	11/01/2016

Labeler - GADAL Laboratories, Inc (841305639)

Establishment
Name	Address	ID/FEI	Business Operations
GADAL Laboratories, Inc		841305639	MANUFACTURE(53113-363)