911 BALM-C by Skinfix, Inc. Skinfix - 911 BALM-C

911 BALM-C by

Drug Labeling and Warnings

911 BALM-C by is a Otc medication manufactured, distributed, or labeled by Skinfix, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• cuts
• scrapes
• burns.

Warnings

For external use only.

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

• condition worsens
• symptoms last more than 7 days or clear up and occur again within a few days.

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

911 BALM-C 
allantoin ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61328-118
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61328-118-51	1 in 1 BOX	08/11/2018	01/03/2020
1	NDC: 61328-118-11	13.5 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	02/27/2017	01/03/2020

Labeler - Skinfix, Inc. (203158183)

Registrant - Skinfix, Inc. (203158183)

Revised: 1/2020

Document Id: 612ef0e3-4a0e-47b5-b01d-c8b576b704e7

34390-5

Set id: 2e6a2b07-1fa7-45b1-ba69-66c689533fe8

Version: 3

Effective Time: 20200103