12 Hour Healing by Skinfix, Inc.

12 Hour Healing by

Drug Labeling and Warnings

12 Hour Healing by is a Otc medication manufactured, distributed, or labeled by Skinfix, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• 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 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	01/03/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	05/02/2017	01/03/2020

Labeler - Skinfix, Inc. (203158183)

Registrant - Skinfix, Inc. (203158183)

Revised: 1/2020

Document Id: 1506d919-f4e4-4aa9-95f6-a4e4cb9317bb

34390-5

Set id: deb8ebdc-756a-48e0-8f04-0ac1f6ca6316

Version: 2

Effective Time: 20200103

 

Skinfix, Inc.