FROZEN ICE FAST PAIN RELIEF- menthol camphor (natural) gel 
GADAL Laboratories, Inc

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.

----------

Gadaderm Frocen Ice FastmPain Releive

ACTIVE INGREDIENT

Active IngredientsPurpose
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.

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

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

Label Image
FROZEN ICE FAST PAIN RELIEF 
menthol camphor (natural) gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53113-363
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3.5 g  in 100 mL
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)0.2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53113-363-0389 mL in 1 APPLICATOR; Type 0: Not a Combination Product11/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/01/2016
Labeler - GADAL Laboratories, Inc (841305639)
Establishment
NameAddressID/FEIBusiness Operations
GADAL Laboratories, Inc841305639MANUFACTURE(53113-363)

Revised: 11/2016
Document Id: e06290e3-85ad-4729-96b0-6f063c656081
Set id: 636cb454-eef9-4509-96cd-7deeb2abd0ac
Version: 2
Effective Time: 20161124
 
GADAL Laboratories, Inc