911 BALM-C- 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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Skinfix - 911 BALM-C

Active Ingredients

Allantoin 1%

Purpose

Skin protectant

Uses

Helps prevent and temporarily protects chafed, chapped or cracked skin and lips. Temporarily protects minor

Warnings

For external use only.

When using this product avoid contact with eyes. Stop use and ask a doctor if

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.

Directions

Apply to affected areas as needed.

OTHER INFORMATION

STORE AT 65-75°F. MAY STAIN FABRICS. FOR ADULTS AND CHILDREN TWO YEARS OF AGE AND OLDER.

Inactive Ingredients

Beeswax, Butyrospermum Parkii (Shea) Butter, Colloidal Oatmeal, Glycine Soja (Soybean) Oil, Paraffin, Petrolatum, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Tocopherol.

QUESTIONS?

1.866.927.2783

Skinfix_911_C_Balm_BOX_V7

Skinfix_911_C_Balm_D19_90mm_V10

911 BALM-C 
allantoin ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61328-118
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
OATMEAL (UNII: 8PI54V663Y)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
SHEA BUTTER (UNII: K49155WL9Y)  
COCONUT OIL (UNII: Q9L0O73W7L)  
PARAFFIN (UNII: I9O0E3H2ZE)  
PETROLATUM (UNII: 4T6H12BN9U)  
ALMOND OIL (UNII: 66YXD4DKO9)  
JOJOBA OIL (UNII: 724GKU717M)  
TOCOPHEROL (UNII: R0ZB2556P8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61328-118-511 in 1 BOX08/11/2018
1NDC:61328-118-1113.5 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34702/27/2017
Labeler - Skinfix, Inc. (203158183)
Registrant - Skinfix, Inc. (203158183)

Revised: 8/2018
Document Id: 3f0f4372-8503-4a09-b2fc-628d11244c3f
Set id: 2e6a2b07-1fa7-45b1-ba69-66c689533fe8
Version: 2
Effective Time: 20180813
 
Skinfix, Inc.