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ICE QUAKE MUSCLE RUB Blue

Dosage form: gel
Ingredients: MENTHOL 2g in 100g
Labeler: Southern Sales & Service, Inc.
NDC Code: 69822-104

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.

ICE QUAKE MUSCLE RUB Gel Blue

Active Ingredients               Purpose

Menthol 2.0%                    Topical Anagesic

Purpose

Topical Analgesic

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
  • sport injuries

Warnings

For external use only

When using this product

  • avoid contact with the eyes
  • do not bandage tightly
  • do not apply to wounds or damaged skin
  • do not use with heating pads or ther heating devices

Stop use and ask a doctor if

condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days

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

Directions

  • adults and children 2 years of age and older; apply to affected area not more than 3 to 4 times daily.
  • children under 2 years of age; do not use, consult doctor

Inactive ingredients carbomer, propylene glycol, methylparaben, isopropyl alcohol, triethanolamine, FD&C Blue #1, water

SSS Grou, LLC Miami, Fl 33183

Ice Quake Muscle Rub Gel
ICE QUAKE MUSCLE RUB BLUE 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69822-104
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) 
PROPYLENE GLYCOL 
METHYLPARABEN 
ISOPROPYL ALCOHOL 
TROLAMINE 
FD&C BLUE NO. 1 
Water 
Packaging
#Item CodePackage Description
1NDC:69822-104-08 227 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/01/2013
Labeler - Southern Sales & Service, Inc. (013114906)
Establishment
NameAddressID/FEIOperations
Southern Sales & Service, Inc.013114906LABEL(69822-104)
Establishment
NameAddressID/FEIOperations
GADAL Laboratories, Inc841305639MANUFACTURE(69822-104)

Revised: 01/2017
 
Southern Sales & Service, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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