SOF SKIN ICY BLUE- menthol gel
Viny Health and Beauty 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 1.0%

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.

Warning

For external use only.

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.

Direction

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.

Other Ingredients

Water,

Isopropyl Alcohol,

Nonoxynol-10,

Camphor,

Carbomer,

Sodium Hydroxide,

Methylchloroisothiazolinone,

Methylisothiazolinone,

Blue 1 (CI 42090).

Keep Out of Reach of Children

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.

icy gel

SOF SKIN ICY BLUE
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76436-133
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
CARBOMER 934 (UNII: Z135WT9208)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
NONOXYNOL-10 (UNII: K7O76887AP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76436-133-08	227 g in 1 JAR; Type 0: Not a Combination Product	03/27/2007	10/26/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	03/27/2007	10/26/2017

Labeler - Viny Health and Beauty Inc (963374942)

Revised: 10/2017

Document Id: 54200274-03aa-4614-a5ab-fbfa1d88bad8

Set id: 9113039e-ace9-49bb-8152-9ec93921fc93

Version: 6

Effective Time: 20171026

Viny Health and Beauty Inc