ICE QUAKE Analgesic Cream White(Methyl Salicylate and Menthol)

ICE QUAKE Analgesic Cream White(Methyl Salicylate and Menthol)

Drug Labeling and Warnings

Drug Details

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ICE QUAKE ANALGESIC CREAM WHITE- methyl salicylate and menthol cream 
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 Analgesic Cream White(Methyl Salicylate and Menthol)

Active Ingredients

Methyl Salicylate 8%

Menthol 2%

Purpose

Topical Analgesic

Uses

Temporarily relieves minor aches and pains of muscles and joints due to:

  • arthritis
  • simple backache
  • bruises
  • strains
  • sprains

Warnings

For external use only.

If pregnant or breast-feeding, ask a health professional before use.

When using this product

  • use only as directed
  • Avoid contact with eyes and mucous membranes
  • do not bandage tightly or use with a heating devices
  • do not apply to wounds or damaged skin
  • Do not apply to irritated skin

Stop use and ask a doctor if

  • condition worsens
  • redness is present
  • irritation develops

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center Immediately.

Directions

Adults and Children 12 Years of Age or Older

  • Apply generously to affected area
  • Massage into painfil area until thoroughly absorbed into skin
  • Repeat as necessary, but no more than 3 to 4 times daily

Mineral oil, Propylene glycol, Cetyl stearyl alcohol, Purified water, Ceteareth-6, Stearyl alcohol, PEG-20 Cetyl/Stearyl Ether, Methylparaben, propylparaben.

Analgesic Cream White

MENTHOL 2%, METHYL SALICYLATE 8%

NET WT 2 OZ (60 g)

Store: At Room Temperature 15° - 30°C (59°- 86°F). Close cap tightly after use.

ICE QUAKE WHITE


Distribute By: SSS group, LLC

Pembroke Pines, FL 33332

Questions or Commnets?

Call 800.213.9370

ICE QUAKE ANALGESIC CREAM WHITE 
methyl salicylate and menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 69822-300
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE8.0 
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.0 
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL (UNII: T5L8T28FGP)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
WATER (UNII: 059QF0KO0R)  
CETEARETH-6 (UNII: 2RJS3559D3)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 69822-300-021 in 1 TUBE; Type 0: Not a Combination Product10/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/01/2016
Labeler - Southern Sales & Service, Inc. (013114906)
Establishment
NameAddressID/FEIBusiness Operations
Southern Sales & Service, Inc.013114906LABEL(69822-300)
Establishment
NameAddressID/FEIBusiness Operations
GADAL Laboratories, Inc841305639MANUFACTURE(69822-300)

Revised: 10/2009
 
Southern Sales & Service, Inc.


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