Label: ICE QUAKE- menthol gel
-
Contains inactivated NDC Code(s)
NDC Code(s): 53113-100-01 - Packager: Gadal Laboratories, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated September 4, 2012
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- PURPOSE
- Uses
-
Warnings
For external use only.
When using this product
- use only as directed
- do not bandage tightly or use with a heating pad
- avoid contact with eyes or mucous membranes
- do not apply to wounds or 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.
-
Directions
adults and children over 18 years:
- apply to affected area
- squeeze desired amount of ICEQUAKE onto affected area
- massage dispensed gel into painful area until thoroughly absorbed
- repeat as necessary, but no more than 3 to 4 times daily.
- IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER
- Inactive Ingredients
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 113 g Tube Label
-
INGREDIENTS AND APPEARANCE
ICE QUAKE
menthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53113-100 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol 16.95 g in 113 g Inactive Ingredients Ingredient Name Strength HYPROMELLOSES (UNII: 3NXW29V3WO) Glycerin (UNII: PDC6A3C0OX) FD&C Blue NO. 1 (UNII: H3R47K3TBD) Carbomer Homopolymer Type C (Allyl Pentaerythritol Crosslinked) (UNII: 4Q93RCW27E) Sodium Hydroxide (UNII: 55X04QC32I) Water (UNII: 059QF0KO0R) Propylene Glycol (UNII: 6DC9Q167V3) Methylparaben (UNII: A2I8C7HI9T) Isopropyl Alcohol (UNII: ND2M416302) Product Characteristics Color BLUE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53113-100-01 113 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part348 08/23/2012 Labeler - Gadal Laboratories, Inc. (841305639) Establishment Name Address ID/FEI Business Operations Gadal Laboratories, Inc. 841305639 MANUFACTURE(53113-100)