SPL v1
SPL
SPL Set ID a7286bd8-8fae-a2b4-e053-2995a90a7a19
Route
TOPICAL
Published
Effective Date 2020-06-03
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) .alpha.-tocopherol Acetate Aminomethylpropanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-06-03

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 , tocopheryl acetate

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 , tocopheryl acetate

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)