Gadaderm Frocen Ice FastmPain Releive

Gadaderm Frocen Ice FastmPain Releive

Drug Labeling and Warnings

Drug Details

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ICE QUAKE ROLL ON- menthol camphor (natural) gel 
Southern Sales & Service, 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.

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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 THIS AND ALL MEDICINE OUT OF REACH OF CHILDREN

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

WARNINGS

For the external use only. Use only as directed.

  • 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.

Stop Use

  • 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.in.

Uses

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 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 at room temperaturewith cap closed tightly.

Distribute by:

SSS Group, LLC.

Pembroke Pines, FL 33332

www.icequakeonline.com

Questions or Comments?

1 800.213.9370

Ice Quake Roll On

Label Image
ICE QUAKE ROLL ON 
menthol camphor (natural) gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 69822-102
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: 69822-102-03 89 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product01/05/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34811/01/2016
Labeler - Southern Sales & Service, Inc. (013114906)
Establishment
NameAddressID/FEIBusiness Operations
Southern Sales & Service, Inc.013114906LABEL(69822-102)
Establishment
NameAddressID/FEIBusiness Operations
GADAL Laboratories, Inc841305639MANUFACTURE(69822-102)

Revised: 1/2017
 
Southern Sales & Service, Inc.


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