PURE-AID BLUE ICE GEL- menthol gel 
Kareway Product, 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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Pure-Aid Blue Ice Gel 8oz

Menthol 1.25%

Topical analgesic

Uses

Temporarily relieves minor aches and pains of muscles and joints associated with

For external use only

Do not use

When using this product

Stop use and ask a doctor if:

If pregnant or breastfeeding

Ask a health professional before use

Keep out of reach of children

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

Directions

Other Information

Inactive Ingredients

carbomer, camphor, FD&C blue no.1, isopropyl alcohol, methylchoroisothiazolinone, methylsothiazolinone, purified water, sodium hydroxide

Pure-Aid Blue Ice Gel

label

PURE-AID BLUE ICE GEL 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0671
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM1.25 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67510-0671-8226.8 g in 1 JAR; Type 0: Not a Combination Product07/20/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/20/2022
Labeler - Kareway Product, Inc.` (121840057)

Revised: 7/2022
Document Id: e44454b5-eae0-4a57-e053-2a95a90a638e
Set id: e4446218-ded9-2699-e053-2995a90ac74d
Version: 1
Effective Time: 20220720
 
Kareway Product, Inc.`