12 Hour Miracle by Skinfix, Inc.

Drug Details [pdf]

12 HOUR MIRACLE- 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.

----------

Active Ingredients

Allantoin 0.5%

Purpose

Skin protectant

Uses

Restores and protects lips, cuticles and dry patches.

Warnings

For external use only.

When using this product

Avoid contact with eyes

KEEP OUT OF REACH OF CHILDREN.

Directions

Apply as needed.

Inactive Ingredients

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

01b LBL_12-Hour Miracle Ointment_V18

12 HOUR MIRACLE
allantoin ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61328-101
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	0.5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 61328-101-51	1 in 1 BOX	05/23/2015	01/03/2020
1	NDC: 61328-101-11	60 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 61328-101-10	10 g in 1 TUBE; Type 0: Not a Combination Product	03/15/2017	01/03/2020
3	NDC: 61328-101-12	102 g in 1 TUBE; Type 0: Not a Combination Product	03/15/2017	01/03/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	05/23/2015	01/03/2020

Labeler - Skinfix, Inc. (203158183)

Registrant - Skinfix, Inc. (203158183)

Revised: 1/2020

Document Id: 64e74e5e-3156-464b-8100-aa9916921a02

Set id: c8ee66c9-6d30-49ad-9965-12692551ead4

Version: 9

Effective Time: 20200103

Trademark Results [12 Hour Miracle]

Mark Image Registration \| Serial	Company Trademark Application Date
12 HOUR MIRACLE 86753108 5067063 Live/Registered	Skinfix Inc. 2015-09-10