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.

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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
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:61328-101-51 1 in 1 BOX 05/23/2015
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
3 NDC:61328-101-12 102 g in 1 TUBE; Type 0: Not a Combination Product 03/15/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 05/23/2015
Labeler - Skinfix, Inc. (203158183)
Registrant - Skinfix, Inc. (203158183)

Revised: 9/2018
Document Id: d413fcc5-de80-4040-9608-135a5434f4fb
Set id: c8ee66c9-6d30-49ad-9965-12692551ead4
Version: 8
Effective Time: 20180914
Skinfix, Inc.