SPL v2
SPL
SPL Set ID aec580ff-8b2c-25f9-e053-2a95a90a4fd9
Route
TOPICAL
Published
Effective Date 2020-09-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (41.3 mL)
Inactive Ingredients
Glycerin Polyoxyl 40 Hydrogenated Castor Oil Water Trolamine Phenoxyethanol Fragrance Lavender & Chia F-153480 Aminomethylpropanol Carbomer Homopolymer, Unspecified Type

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-09-08
Description

Store below 110°F (43"C). May discolor certain fabrics or surfaces.

Medication Information

Warnings and Precautions

For external use only, Flammable. Keep product away from fire or flame.

Indications and Usage

●Place enough product on your palm to thoroughly cover your hands.

●Rub hands together biskly until dry.

●Children under 6 years of age should be supevised when using this product.

Dosage and Administration

Store below 110°F (43"C). May discolor certain fabrics or surfaces.

Description

Store below 110°F (43"C). May discolor certain fabrics or surfaces.

Section 50565-1

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

Section 51727-6

WATER

GLYCERIN

PEG-40 Hydrogenated Castor Oil

CARBOMER

TRIETHANOLAMINE

Phenoxyethanol

Parfum (Fragrance)

Aminomethy propanol

Section 51945-4

Section 55105-1

Disinfection

Sterilization

No Rinseing

Section 55106-9

Alcohol

Structured Label Content

Indications and Usage (34067-9)

●Place enough product on your palm to thoroughly cover your hands.

●Rub hands together biskly until dry.

●Children under 6 years of age should be supevised when using this product.

Dosage and Administration (34068-7)

Store below 110°F (43"C). May discolor certain fabrics or surfaces.

Warnings and Precautions (34071-1)

For external use only, Flammable. Keep product away from fire or flame.

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

WATER

GLYCERIN

PEG-40 Hydrogenated Castor Oil

CARBOMER

TRIETHANOLAMINE

Phenoxyethanol

Parfum (Fragrance)

Aminomethy propanol

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Disinfection

Sterilization

No Rinseing

Section 55106-9 (55106-9)

Alcohol

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:59:08.637876 · Updated: 2026-03-14T22:59:00.992624