Sof Skin Icy Blue

Dosage form: gel
Ingredients: Menthol 1g in 100g
Labeler: Viny Health and Beauty Inc
NDC Code: 76436-133

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.

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.



SOF SKIN ICY BLUE 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76436-133
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (Menthol) Menthol1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
ISOPROPYL ALCOHOL 
CAMPHOR (SYNTHETIC) 
CARBOMER 934 
SODIUM HYDROXIDE 
METHYLISOTHIAZOLINONE 
METHYLCHLOROISOTHIAZOLINONE  
NONOXYNOL-10 
FD&C BLUE NO. 1 
Packaging
#Item CodePackage Description
1NDC:76436-133-08227 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/27/2007
Labeler - Viny Health and Beauty Inc (963374942)

Revised: 10/2014
 
Viny Health and Beauty Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web4)