FDA.reportPublic FDA data

911 BALM-C

Manufacturer
Skinfix, Inc.
Effective date
2018-08-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:52:49

Label at a glance#

Product911 BALM-C
Active ingredientALLANTOIN
Label structure10 sections

Indications and uses

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

Dosage and administration

Apply to affected areas as needed.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Allantoin 1%

Purpose

OTC - PURPOSE SECTION

Skin protectant

Uses

INDICATIONS & USAGE SECTION

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

  • cuts
  • scrapes
  • burns.

Warnings

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Apply to affected areas as needed.

OTHER INFORMATION

OTHER SAFETY INFORMATION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

1.866.927.2783

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Skinfix_911_C_Balm_BOX_V7Skinfix_911_C_Balm_BOX_V7

Skinfix_911_C_Balm_D19_90mm_V10Skinfix_911_C_Balm_D19_90mm_V10

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61328-11861328-118-11, 61328-118-51

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
OATMEAL8PI54V663YIACT
ALLANTOIN344S277G0ZACTIB
YELLOW WAX2ZA36H0S2VIACT
SHEA BUTTERK49155WL9YIACT
COCONUT OILQ9L0O73W7LIACT
PARAFFINI9O0E3H2ZEIACT
PETROLATUM4T6H12BN9UIACT
ALMOND OIL66YXD4DKO9IACT
JOJOBA OIL724GKU717MIACT
TOCOPHEROLR0ZB2556P8IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
3f0f4372-8503-4a09-b2fc-628d11244c3f2e6a2b07-1fa7-45b1-ba69-66c689533fe82018-08-13WarningsExact identifier
spl id: 3f0f4372-8503-4a09-b2fc-628d11244c3f
spl set id: 2e6a2b07-1fa7-45b1-ba69-66c689533fe8

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.