Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID a56d09e4-db8b-7443-e053-2995a90aa22e
Route
TOPICAL
Published
Effective Date 2020-03-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (42 mL)
Inactive Ingredients
Carbomer Homopolymer, Unspecified Type Glycerin Aloe Trolamine Water Chamomile Green Tea Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-05-01

Description

Alcohol


Medication Information

Warnings and Precautions

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

Do not use

■ in children less than 2 months of age

■ on open skin wounds

when using this product keep out of eyes, ears, and mouth.

Stop use and ask a doctor if irritation or rash occurs. these may be signs of a serious condition.

Keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.

Indications and Usage

■ Store between 1-30C

■ Avoid freezing and excessive heat above 40C

Dosage and Administration

■ Place enough product on hands to cover all surfaces. Rub hands together until dry.

■ Supervise children under 6 years of age when using this product to avoid swallowing.

Description

Alcohol

Section 50565-1

KEEP OUT OF REACH OF THE CHILDREN

Section 51727-6

Water, Glycerin, Triethanolamine, Carbomer, Green Tea Extract, Aloe Extract, Sage Extract, Matricaria(Chamomilla) Extract

Section 51945-4

Section 55105-1

Antimicrobial

Section 55106-9

Alcohol


Structured Label Content

Indications and Usage (34067-9)

■ Store between 1-30C

■ Avoid freezing and excessive heat above 40C

Dosage and Administration (34068-7)

■ Place enough product on hands to cover all surfaces. Rub hands together until dry.

■ Supervise children under 6 years of age when using this product to avoid swallowing.

Warnings and Precautions (34071-1)

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

Do not use

■ in children less than 2 months of age

■ on open skin wounds

when using this product keep out of eyes, ears, and mouth.

Stop use and ask a doctor if irritation or rash occurs. these may be signs of a serious condition.

Keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF THE CHILDREN

Section 51727-6 (51727-6)

Water, Glycerin, Triethanolamine, Carbomer, Green Tea Extract, Aloe Extract, Sage Extract, Matricaria(Chamomilla) Extract

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antimicrobial

Section 55106-9 (55106-9)

Alcohol


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)