SPL v1
SPL
SPL Set ID ab8f0e24-fbe8-fb27-e053-2995a90ab3a5
Route
TOPICAL
Published
Effective Date 2020-07-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (375 mL)
Inactive Ingredients
Water Carbomer Homopolymer, Unspecified Type Trolamine Propylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-07-29

Description

Store in a cool and dry place


Medication Information

Warnings and Precautions

For external use only. Do not use in or near the eyes. In case of contact with eyes, flush thoroughly with water. Do not swallow. If swallowed, seek medical help or contact a Poison Control Center immediately. Avoid contact with broken skin. Seek medical help if irritation or redness develops and condition continues for more than 72 hours. KEEP OUT OF REACH OF CHILDREN. Can be used

on children under adult supervision. Not recommended for infants.

Indications and Usage

Place enough gel into your palm to thoroughly .spread on both hands (front & back) and rub into the skin until dry.

Dosage and Administration

Store in a cool and dry place

Description

Store in a cool and dry place

Section 50565-1

keep out of reach of children

Section 51727-6

Water,carbomer, triethanolamine,propylene glycol

Section 51945-4

Section 55105-1

Disinfection

Sterilization

No Rinseing

Section 55106-9

ethanol


Structured Label Content

Indications and Usage (34067-9)

Place enough gel into your palm to thoroughly .spread on both hands (front & back) and rub into the skin until dry.

Dosage and Administration (34068-7)

Store in a cool and dry place

Warnings and Precautions (34071-1)

For external use only. Do not use in or near the eyes. In case of contact with eyes, flush thoroughly with water. Do not swallow. If swallowed, seek medical help or contact a Poison Control Center immediately. Avoid contact with broken skin. Seek medical help if irritation or redness develops and condition continues for more than 72 hours. KEEP OUT OF REACH OF CHILDREN. Can be used

on children under adult supervision. Not recommended for infants.

Section 50565-1 (50565-1)

keep out of reach of children

Section 51727-6 (51727-6)

Water,carbomer, triethanolamine,propylene glycol

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Disinfection

Sterilization

No Rinseing

Section 55106-9 (55106-9)

ethanol


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)