12 HOUR HEALING- allantoin ointment 
Skinfix, 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 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

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.

Skinfix_12HR_US_4oz_V6_OL_R

12 HOUR HEALING 
allantoin ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:61328-116
Route of Administration TOPICAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN 0.5 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
LEVOMENOL (UNII: 24WE03BX2T)  
SHEANUT OIL (UNII: O88E196QRF)  
COCONUT OIL (UNII: Q9L0O73W7L)  
THEOBROMA GRANDIFLORUM SEED BUTTER (UNII: I711F13FXM)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
PETROLATUM (UNII: 4T6H12BN9U)  
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)  
JOJOBA OIL (UNII: 724GKU717M)  
TOCOPHEROL (UNII: R0ZB2556P8)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:61328-116-11 102 g in 1 TUBE; Type 0: Not a Combination Product 05/02/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 05/02/2017
Labeler - Skinfix, Inc. (203158183)
Registrant - Skinfix, Inc. (203158183)

Revised: 5/2017
Document Id: cc35868f-2f0b-4832-a936-479f4cc19da8
Set id: deb8ebdc-756a-48e0-8f04-0ac1f6ca6316
Version: 1
Effective Time: 20170502
 
Skinfix, Inc.