SPL v1
SPL
SPL Set ID 6a9564a8-ad0e-4e28-b216-36b84be5c629
Route
TOPICAL
Published
Effective Date 2013-07-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (37 mL)
Inactive Ingredients
Aloe Vera Leaf Carbomer Homopolymer Type B Glycerin Propylene Glycol .alpha.-tocopherol Acetate Trolamine Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2013-07-05

Description

Active Ingredient Purpose Ethyl Alcohol 62.0%......................Antimicrobial


Medication Information

Warnings and Precautions

Warnings:

for external use only.

Flammable. Keep away from heat and flame.

Do not use in the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.

Indications and Usage

USE: 

  • for handwashing to decrease bacteria on the skin
  • recommended for repeated use
Dosage and Administration

Directions:

  • wet hands thoroughly with product
  • briskly rub hands together until dry
  • supervise children in the use of this product
Description

Active Ingredient Purpose Ethyl Alcohol 62.0%......................Antimicrobial

Section 50565-1

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6

Inactive ingredients:

aloe vera leaf juice, carbomer, glycerin, propylene glycol, tocopheryl acetate (vitamin E), triethanolamine, water.

Section 51945-4

Section 55105-1

Health Care Instant Hand Sanitizer - Ice Clear - Extra Enriched with Vitamin E Bead & Aloe

Kills 99.9% of Germs without water or towels!

Section 55106-9

Active Ingredient Purpose

Ethyl Alcohol 62.0%......................Antimicrobial

Section 60561-8

Other information:

  • store at 20oC to 25oC (68o to 77oF)
  • may discolor certain fabrics

Structured Label Content

Indications and Usage (34067-9)

USE: 

  • for handwashing to decrease bacteria on the skin
  • recommended for repeated use
Dosage and Administration (34068-7)

Directions:

  • wet hands thoroughly with product
  • briskly rub hands together until dry
  • supervise children in the use of this product
Warnings and Precautions (34071-1)

Warnings:

for external use only.

Flammable. Keep away from heat and flame.

Do not use in the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.

Section 50565-1 (50565-1)

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Inactive ingredients:

aloe vera leaf juice, carbomer, glycerin, propylene glycol, tocopheryl acetate (vitamin E), triethanolamine, water.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Health Care Instant Hand Sanitizer - Ice Clear - Extra Enriched with Vitamin E Bead & Aloe

Kills 99.9% of Germs without water or towels!

Section 55106-9 (55106-9)

Active Ingredient Purpose

Ethyl Alcohol 62.0%......................Antimicrobial

Section 60561-8 (60561-8)

Other information:

  • store at 20oC to 25oC (68o to 77oF)
  • may discolor certain fabrics

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)