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 TypeHUMAN OTC DRUGItem Code (Source)NDC:61328-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61328-101-511 in 1 BOX05/23/201501/03/2020
1NDC:61328-101-1160 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:61328-101-1010 g in 1 TUBE; Type 0: Not a Combination Product03/15/201701/03/2020
3NDC:61328-101-12102 g in 1 TUBE; Type 0: Not a Combination Product03/15/201701/03/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34705/23/201501/03/2020
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
 
Skinfix, Inc.