SKINFIX - 911 OINTMENT (61328-120)

Manufacturer
Skinfix, Inc. | Canadian Custom Packaging Company
Effective date
2025-12-29
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:29:32

Label at a glance#

Product911
Active ingredientALLANTOIN
Label structure8 sections

Indications and uses

Restores and protects lips, cuticles and dry patches.

Dosage and administration

Apply as needed.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Allantoin 0.5%

Purpose

OTC - PURPOSE SECTION

Skin protectant

Uses

INDICATIONS & USAGE SECTION

Restores and protects lips, cuticles and dry patches.

Warnings

WARNINGS SECTION

For external use only.

OTC - WHEN USING SECTION

When using this product

  • Avoid contact with eyes

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply as needed.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Skinfix_US_911_Ointment_BOX_V4_R - boxSkinfix_US_911_Ointment_BOX_V4_R - box

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1044541allantoin 0.5 % Topical OintmentPSN7
1044541allantoin 0.005 MG/MG Topical OintmentSCD7
1044541allantoin 0.5 % Topical StickSY7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61328-120-1191150 g in 1 TUBEOINTMENT507
61328-120-129118.5 g in 1 TUBEOINTMENT8.57

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61328-12061328-120-11, 61328-120-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

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
911ALLANTOINSkinfix, Inc.f28c251e-a91b-4ed4-8224-b47c345f982f2025-12-29WarningsExact identifier
ndc (package): 61328-120-11
ndc (package): 61328-120-12
ndc (product): 61328-120
ndc11 (package): 61328012011
ndc11 (package): 61328012012
spl id: 471aac11-1c14-86fa-e063-6294a90a082e
spl set id: f28c251e-a91b-4ed4-8224-b47c345f982f

Reported adverse events (FAERS/openFDA)#

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