Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID b743b871-54f1-00de-e053-2995a90a4d04
Route
TOPICAL
Published
Effective Date 2020-12-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (60 mL)
Inactive Ingredients
Glycerin Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-12-25

Description

alcohol


Medication Information

Warnings and Precautions

■ Flammable. Keep away from fire or flame.

■ For external use only.

■ Do not use in eyes.

■ lf swallowed, get medical help promptly.

■ Stop use, ask doctor lf irritation occurs.

■ Keep out of reach of children.

Indications and Usage

take appropriate amount where needed

Dosage and Administration

for external use only

Description

alcohol

Section 50565-1

KEEP OUT OF REACH OF THE CHILDREN

Section 51727-6

Alcohol, Water, Glycerin, Isopropyl Myristate, Triethanolamine, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Citrus Paradisi (Grapefruit) Seed Oil, Ethylhexylglycerin, Eucalyptus Globulus Leaf Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, 1,2-Hexanediol, Aloe Barbadensis Leaf Extract, Butylene Glycol, Centella Asiatica Extract, Polygonum Cuspidatum Root Extract, Scutellaria Baicalensis Root Extract, Camellia Sinensis Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract

Section 51945-4

Section 55105-1

sterilization, disinfection

Section 55106-9

alcohol


Structured Label Content

Indications and Usage (34067-9)

take appropriate amount where needed

Dosage and Administration (34068-7)

for external use only

Warnings and Precautions (34071-1)

■ Flammable. Keep away from fire or flame.

■ For external use only.

■ Do not use in eyes.

■ lf swallowed, get medical help promptly.

■ Stop use, ask doctor lf irritation occurs.

■ Keep out of reach of children.

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF THE CHILDREN

Section 51727-6 (51727-6)

Alcohol, Water, Glycerin, Isopropyl Myristate, Triethanolamine, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Citrus Paradisi (Grapefruit) Seed Oil, Ethylhexylglycerin, Eucalyptus Globulus Leaf Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, 1,2-Hexanediol, Aloe Barbadensis Leaf Extract, Butylene Glycol, Centella Asiatica Extract, Polygonum Cuspidatum Root Extract, Scutellaria Baicalensis Root Extract, Camellia Sinensis Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

sterilization, disinfection

Section 55106-9 (55106-9)

alcohol


Advanced Ingredient Data


Raw Label Data

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