VHB - Sof Skin Icy Blue Gel (76436-140) - DELIST

ICY BLUE by

Drug Labeling and Warnings

ICY BLUE by is a Otc medication manufactured, distributed, or labeled by Viny Health and Beauty Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ICY BLUE- menthol gel 
Viny Health and Beauty Inc

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VHB - Sof Skin Icy Blue Gel (76436-140) - DELIST

ACTIVE INGREDIENTS

MENTHOL BP 1.0% W/W

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 LINIMINT. DO NOT BANDAGE.

DO NOT USE WITH HEATING PADS OR HEATING DEVICES.

IF CONDITION WORSENS OR SYMPTOMS PERSIST FOR MORE THEN 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 PROTECTIV COVER NEEDED. DO NOT APPLY TO CHILDREN UNDER 2 YEARS OF AGE.

OTHER INGREDIENTS

CARBOMER 940 USP/NF, CAMPHOR BP, PROPYLENE GLYCOL BP, SODIUM METHYL PARABEN BP, SODIUM PROPYL PARABEN BP, DISODIUM EDTA BP, IMID UREA USP/NF, ISOPROPYL ALCOHOL BP, SODIUM HYDROXIDE BP, POLYOXYL 40HCO USP.

ICY BLUE 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76436-140
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
IMIDUREA (UNII: M629807ATL)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)
PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
CARBOMER 940 (UNII: 4Q93RCW27E)
CAMPHOR OIL (UNII: 75IZZ8Y727)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76436-140-17	200 g in 1 JAR; Type 0: Not a Combination Product	07/16/2022	12/31/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	03/10/2010	12/31/2023

Labeler - Viny Health and Beauty Inc (079977276)

Revised: 2/2024

Document Id: 1279d8e4-bad7-a208-e063-6394a90a7a77

34390-5

Set id: e3ee7694-6d7b-4807-e053-2a95a90a1fd7

Version: 3

Effective Time: 20240228