12 Hour Healing

Manufacturer: Skinfix, Inc.
Effective date: 2017-05-02
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: legacy-cache
Hydrated at: 2026-08-02 01:16:38

Label at a glance#

Product12 Hour Healing

Active ingredientALLANTOIN

Label structure11 sections

Indications and uses

HELPS HEAL DRY, CHAPPED OR CRACKED SKIN. tEMPORARILY PROTECTS MINOR CUTS, SCRAPES, AND BURNS.

Dosage and administration

APPLY GENEROUSLY AS NEEDED TO IRRITATED OR AFFECTED SKIN.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Allantoin 0.5%

Purpose

OTC - PURPOSE SECTION

Skin protectant

Uses

INDICATIONS & USAGE SECTION

HELPS HEAL DRY, CHAPPED OR CRACKED SKIN. tEMPORARILY PROTECTS MINOR CUTS, SCRAPES, AND BURNS.

Warnings

WARNINGS SECTION

For external use only.

OTC - WHEN USING SECTION

When using this product

Avoid contact with eyes

OTC - WHEN USING SECTION

WHEN USING THIS PRODUCT: AVOID CONTACT WITH EYES.

OTC - STOP USE SECTION

STOP USE AND ASK A DOCTOR IF

CONDITIONS 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.

Directions

DOSAGE & ADMINISTRATION SECTION

APPLY GENEROUSLY AS NEEDED TO IRRITATED OR AFFECTED SKIN.

OTHER INFORMATION

OTHER SAFETY INFORMATION

STORE AT 65 - 80°F. MAY STAIN FABRICS. FOR ADULTS AND CHILDREN TWO YEARS OF AGE AND OLDER.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Extract, Beeswax, Bisabolol, Butyrospermum Parkii (Shea) Butter, Cocos Nucifera (Coconut) Oil, Helianthus Annuus (Sunflower) Seed Oil, Petrolatum, Rosa Canina Fruit Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Cupuacu (Theobroma Grandiflorum) Seed Butter, Tocopherol.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Skinfix_12HR_US_4oz_V6_OL_R

Products#

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

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

12 Hour Healing
Allantoin
ALOE VERA LEAF
YELLOW WAX
LEVOMENOL
SHEANUT OIL
COCONUT OIL
THEOBROMA GRANDIFLORUM SEED BUTTER
SUNFLOWER OIL
PETROLATUM
ROSA CANINA FRUIT OIL
JOJOBA OIL
TOCOPHEROL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
61328-116	61328-116-11

Ingredients#

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

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

Name, UNII, Kind table
Name	UNII	Kind
ALLANTOIN	344S277G0Z	ACTIB
ALOE VERA LEAF	ZY81Z83H0X	IACT
YELLOW WAX	2ZA36H0S2V	IACT
LEVOMENOL	24WE03BX2T	IACT
SHEANUT OIL	O88E196QRF	IACT
COCONUT OIL	Q9L0O73W7L	IACT
THEOBROMA GRANDIFLORUM SEED BUTTER	I711F13FXM	IACT
SUNFLOWER OIL	3W1JG795YI	IACT
PETROLATUM	4T6H12BN9U	IACT
ROSA CANINA FRUIT OIL	CR7307M3QZ	IACT
JOJOBA OIL	724GKU717M	IACT
TOCOPHEROL	R0ZB2556P8	IACT

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
cc35868f-2f0b-4832-a936-479f4cc19da8			deb8ebdc-756a-48e0-8f04-0ac1f6ca6316	2017-05-02	Warnings	Exact identifier spl id: cc35868f-2f0b-4832-a936-479f4cc19da8 spl set id: deb8ebdc-756a-48e0-8f04-0ac1f6ca6316

Reported adverse events (FAERS/openFDA)#

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