ICE QUAKE MUSCLE RUB Gel Blue

ICE QUAKE MUSCLE RUB Gel Blue

Drug Labeling and Warnings

Drug Details

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ICE QUAKE MUSCLE RUB BLUE- menthol 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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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

Label Image
ICE QUAKE MUSCLE RUB BLUE 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 69822-104
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
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: 69822-104-08 227 g in 1 JAR; Type 0: Not a Combination Product01/04/2017
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/FEIBusiness Operations
Southern Sales & Service, Inc.013114906LABEL(69822-104)
Establishment
NameAddressID/FEIBusiness Operations
GADAL Laboratories, Inc841305639MANUFACTURE(69822-104)

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


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