ICY BLUE- menthol gel 
MY IMPORT USA 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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Active Ingredient

MENTHOL 1%

Purpose

TOPICAL ANALGESIC

Uses

PROVIDES TEMPORARY RELIEF OF MINOR ACHES AND PAINS IN MUSCLES AND JOINTS ASSOCIATED WITH SIMPLE BACKACHE, STRAINS, SPRAINS, ARTHRITIS AND SPORTS INJURIES.

Warnings

For external use only. NOT FOR INTERNAL USE.

​USE ONLY AS DIRECTED. AVOID CONTACT WITH EYES OR MUCOUS MEMBRANES. DO NOT APPLY TO OPEN WOUNDS OR DAMAGED SKIN. MAKE SURE SKIN IS CLEAN AND FREE FROM ANY CREAMS, OINTMENTS, SPRAYS OR LINIMENT. DO NOT BANDAGE.

DO NOT USE WITH HEATING PADS OR HEATING DEVICES.

IF CONDITION WORSENS OR SYMPTOMS PERSIST FOR MORE THAN 7 DAYS OR IF SYMPTOMS DISAPPEAR AND OCCUR AGAIN WITHIN A FEW DAYS, DISCONTINUE USE AND CONSULT A PHYSICIAN. IF YOU HAVE SENSITIVE SKIN, CONSULT A PHYSICIAN BEFORE USE. IF SKIN IRRITATION DEVELOPS, DISCONTINUE USE AND CONSULT A PHYSICIAN. IF YOU ARE PREGNANT OR NURSING A BABY, CONSULT YOUR DOCTOR BEFORE USE. DO NOT USE, STORE, POUR OR SPILL NEAR HEAT OR OPEN FLAME. STORE IN A COOL, DRY PLACE AND KEEP LID TIGHTLY CLOSED.

KEEP OUT OF REACH OF CHILDREN.

DIRECTIONS

CLEAN SKIN OF ALL OTHER LOTIONS, CREAMS, OINTMENTS, LINIMENT OR SPRAYS. APPLY LIBERALLY TO AFFECTED AREA AND MASSAGE UNTIL GEL IS ABSORBED INTO SKIN. DO NOT APPLY MORE THAN 3 OR 4 TIMES DAILY. NO PROTECTIVE COVER NEEDED. DO NOT APPLY TO CHILDREN UNDER 2 YEARS OF AGE.

Inactive Ingredients

WATER, ISOPROPYL ALCOHOL, NONOXYNOL-10, CAMPHOR, CARBOMER, SODIUM HYDROXIDE, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, BLUE 1 (CI 42090).

Icy Blue Gel - B

ICY BLUE 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51628-1009
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
NONOXYNOL-10 (UNII: K7O76887AP)  
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51628-1009-1227 g in 1 JAR; Type 0: Not a Combination Product03/26/201502/10/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/26/201502/10/2017
Labeler - MY IMPORT USA INC (195767988)

Revised: 2/2017
 
MY IMPORT USA INC