SPL v1
SPL
SPL Set ID a47a302d-c7b9-5286-e053-2a95a90aaab2
Route
TOPICAL
Published
Effective Date 2020-04-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Maltodextrin Propylene Glycol Water Aloe Vera Leaf Glycerin Carbomer Interpolymer Type A (55000 Cps) Aminomethylpropanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-04-30

Description

Active Ingredient Ethyl Alcohol 70%


Medication Information

Warnings and Precautions

Warnings

for external use only: hands

Flammable. Keep away from fire or flame

Indications and Usage

Uses to decrease bacteria on the skin that could cause disease recommended for repeated use

Dosage and Administration

Directions. wet hands thoroughly with product and allow to dry without wiping. for children under 6 , use only under adult supervision. not recommented for infants.

Description

Active Ingredient Ethyl Alcohol 70%

Section 44425-7

Other information. do not store above 105°F, may discolor some fabics. harmful to wood finished and plastics

Section 50565-1

Keep out of reach of children. if swallowed, get medical help or contact a poison control center(1-800-222-1222)right away .

Section 50566-9

Stop use and ask a doctor if . irritation or redness develops. condition persists for more than 72 hours

Section 50567-7

when using this product, keep out of eyes. In case of contact with eyes, flush thoroughly with water. avoid contact with broken skin. do not inhale or ingest.

Section 51727-6

Inactive ingredients acrylates/C10-C30 alkyl acrylate crosspolymer,aloe barbadensis leaf juice, aminomethyl propanol, glycerin, maltodextrin, propylene glycol, water

Section 51945-4

Section 55105-1

Purpose

Antiseptic

Section 55106-9

Active Ingredient

Ethyl Alcohol 70%


Structured Label Content

Indications and Usage (34067-9)

Uses to decrease bacteria on the skin that could cause disease recommended for repeated use

Dosage and Administration (34068-7)

Directions. wet hands thoroughly with product and allow to dry without wiping. for children under 6 , use only under adult supervision. not recommented for infants.

Warnings and Precautions (34071-1)

Warnings

for external use only: hands

Flammable. Keep away from fire or flame

Section 44425-7 (44425-7)

Other information. do not store above 105°F, may discolor some fabics. harmful to wood finished and plastics

Section 50565-1 (50565-1)

Keep out of reach of children. if swallowed, get medical help or contact a poison control center(1-800-222-1222)right away .

Section 50566-9 (50566-9)

Stop use and ask a doctor if . irritation or redness develops. condition persists for more than 72 hours

Section 50567-7 (50567-7)

when using this product, keep out of eyes. In case of contact with eyes, flush thoroughly with water. avoid contact with broken skin. do not inhale or ingest.

Section 51727-6 (51727-6)

Inactive ingredients acrylates/C10-C30 alkyl acrylate crosspolymer,aloe barbadensis leaf juice, aminomethyl propanol, glycerin, maltodextrin, propylene glycol, water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Antiseptic

Section 55106-9 (55106-9)

Active Ingredient

Ethyl Alcohol 70%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)