911 by Skinfix, Inc. / Canadian Custom Packaging Company 911- allantoin ointment

911 by

Drug Labeling and Warnings

911 by is a Otc medication manufactured, distributed, or labeled by Skinfix, Inc., Canadian Custom Packaging Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

911 
allantoin ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61328-120
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: 61328-120-11	50 g in 1 TUBE; Type 0: Not a Combination Product	12/26/2018
2	NDC: 61328-120-12	8.5 g in 1 TUBE; Type 0: Not a Combination Product	12/26/2018
3	NDC: 61328-120-13	102 g in 1 TUBE; Type 0: Not a Combination Product	05/17/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	12/26/2018

Labeler - Skinfix, Inc. (203158183)

Registrant - Skinfix, Inc. (203158183)