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12 Hour Healing by Skinfix, Inc.

Medically reviewed on May 2, 2017

Dosage form: ointment
Ingredients: ALLANTOIN 0.5g in 100g
Labeler: Skinfix, Inc.
NDC Code: 61328-116

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 Ingredients

Allantoin 0.5%

Purpose

Skin protectant

Uses

HELPS HEAL DRY, CHAPPED OR CRACKED SKIN. tEMPORARILY PROTECTS MINOR CUTS, SCRAPES, AND BURNS.

Warnings

For external use only.

When using this product

  • Avoid contact with eyes

WHEN USING THIS PRODUCT: AVOID CONTACT WITH EYES.

STOP USE AND ASK A DOCTOR IF

  • CONDITIONS WORSENS
  • SYMPTOMS LAST MORE THAN 7 DAYS OR CLEAR UP AND OCCUR AGAIN WITHIN A FEW DAYS.

KEEP OUT OF REACH OF CHILDREN.

Directions

APPLY GENEROUSLY AS NEEDED TO IRRITATED OR AFFECTED SKIN.

OTHER INFORMATION

STORE AT 65 - 80°F. MAY STAIN FABRICS. FOR ADULTS AND CHILDREN TWO YEARS OF AGE AND OLDER.

Inactive Ingredients

Aloe Barbadensis Leaf Extract, Beeswax, Bisabolol, Butyrospermum Parkii (Shea) Butter, Cocos Nucifera (Coconut) Oil, Helianthus Annuus (Sunflower) Seed Oil, Petrolatum, Rosa Canina Fruit Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Cupuacu (Theobroma Grandiflorum) Seed Butter, Tocopherol.

12 HOUR HEALING 
allantoin ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61328-116
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALLANTOIN (ALLANTOIN) ALLANTOIN0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
YELLOW WAX 
LEVOMENOL 
SHEANUT OIL 
COCONUT OIL 
THEOBROMA GRANDIFLORUM SEED BUTTER 
SUNFLOWER OIL 
PETROLATUM 
ROSA CANINA FRUIT OIL 
JOJOBA OIL 
TOCOPHEROL 
Packaging
#Item CodePackage Description
1NDC:61328-116-11102 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34705/02/2017
Labeler - Skinfix, Inc. (203158183)
Registrant - Skinfix, Inc. (203158183)

 
Skinfix, Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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