PURE-AID BLUE ICE GEL- menthol gel

Pure-Aid Blue Ice Gel by

Drug Labeling and Warnings

Pure-Aid Blue Ice Gel by is a Otc medication manufactured, distributed, or labeled by Kareway Product, Inc.`. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Menthol 1.25%

PURPOSE

Topical analgesic

Uses

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

• simple backache
• arthritis
• strains
• bruises
• sprains

WARNINGS

For external use only

Do not use

• Do not use with other topical pain relievers
• Do not use with heating pads or other heating devices

When using this product

• do not use in or near the eyes
• do not apply to wounds or damaged skin
• do not bandage tightly

Stop use and ask a doctor if:

• condition worsens
• symptoms last more than 7 day or clear up and occur again withing a few days

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

• Clean affected area before applying product
• Adults and children 2 years and older: apply to the affected area not more than 3 to 4 times daily
• Children under 2 years of age: ask a doctor before using this product

Other Information

• Store at 20ºC-25ºC (68º-77ºF) in a tightly closed container
• store in a cool place
• do not use, pour, spill or store near heat or open flame

Inactive Ingredients

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

Pure-Aid Blue Ice Gel

INGREDIENTS AND APPEARANCE

PURE-AID BLUE ICE GEL 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67510-0671
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	1.25 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67510-0671-8	226.8 g in 1 JAR; Type 0: Not a Combination Product	07/20/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	07/20/2022

Labeler - Kareway Product, Inc.` (121840057)