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Ice Quake Plus by Southern Sales & Service, Inc.

Dosage form: cream
Ingredients: MENTHOL 10g in 100g, METHYL SALICYLATE 10g in 100g, CAMPHOR (SYNTHETIC) 3.1g in 100g
Labeler: Southern Sales & Service, Inc.
NDC Code: 69822-101

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.

Active Ingredients               Purpose

Methyl Salicylate  10%      Topical Analgesic

Menthol 10%                    Topical Analgesic

Camphor 3.1%                 Topical Analgesic

Purpose

Topical Analgesic

Uses

temporarily relieves minor pain associated with

  • Arthritis
  • Smple backache
  • Strains
  • Bruises
  • Pprains
  • Cramps

Warnings

For external use only

IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER

Stop use and ask a doctor if
  • condition worsens
  • redness is present
  • irritation develops

When using this product:
  • Use only as directed
  • Do not bandage tightly
  • Do not use with a heating devices
  • Avoid contact with the eyes and mucous membranes
  • Do not apply to wounds, damaged, broken or irritated skin
  • If severe burning sensation occurs, discontinue use immediately
  • Do not expose the area treated with product to heat or direct sunlight

Keep out of reach of children.

 If swallowed get medical help or contact a Poison Control Center right away.

Directions

  • adults and children over 18 years and older:
  • Apply to affected area
  • Squeeze desired amount of IceQuake Plus onto affected area
  • massage dispensed cream into painful area until thoroughly absorbed
  • Repeat as necessary, but no more than 3 to 4 times daily

Inactive ingredients: HPMC, glycerin, FD&C Blue No.1, carbopol, isopropyl alcohol, propylene glycol, methylparaben, sodium hydroxide, water

DISTRIBUTE BY:

SSS Group, LLC Pembroke Pines, Fl 33332

Questions or Comments?

Call 1 800.213.9370

ICE QUAKE PLUS
ICE QUAKE  PLUS
methyl salicylate, menthol, camphor cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69822-101
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL10 g  in 100 g
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE10 g  in 100 g
CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC)3.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSE 2910 (10000 MPA.S) 
GLYCERIN 
FD&C BLUE NO. 1 
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) 
ISOPROPYL ALCOHOL 
PROPYLENE GLYCOL 
METHYLPARABEN 
SODIUM HYDROXIDE 
WATER 
Packaging
#Item CodePackage Description
1NDC:69822-101-04 113 g in 1 TUBE
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(69822-101)
Establishment
NameAddressID/FEIOperations
GADAL Laboratories, Inc841305639MANUFACTURE(69822-101)

 
Southern Sales & Service, Inc.

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Medically reviewed on Jan 5, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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