SPL v1
SPL
SPL Set ID 18a43449-b04b-4a66-9de0-0ccace9a98d7
Route
TOPICAL
Published
Effective Date 2013-07-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (146 mL)
Inactive Ingredients
Water Trolamine Glycerin Propylene Glycol Titanium Dioxide Aloe Vera Leaf Carbomer Homopolymer Type B

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2013-07-03

Description

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


Medication Information

Warnings and Precautions

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
  • 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 under 6 years in the use of this product
Description

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

water, carbomer, triethanolamine, glycerin, propylene glycol, fragrance, titanium dioxide, aloe barbadensis leaf juice.

Section 51945-4

Section 55105-1

XtraCare Instant Hand Sanitizer Aloe Vera

kills 99.9% of germs

with Moisturizers & Aloe Vera

Section 55106-9

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

Section 60561-8
  • store at 20oC to 25oC (68o to 77oF)
  • may discolor certain fabrics

Structured Label Content

Indications and Usage (34067-9)
  • 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 under 6 years in the use of this product
Warnings and Precautions (34071-1)

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)

water, carbomer, triethanolamine, glycerin, propylene glycol, fragrance, titanium dioxide, aloe barbadensis leaf juice.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

XtraCare Instant Hand Sanitizer Aloe Vera

kills 99.9% of germs

with Moisturizers & Aloe Vera

Section 55106-9 (55106-9)

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

Section 60561-8 (60561-8)
  • store at 20oC to 25oC (68o to 77oF)
  • may discolor certain fabrics

Advanced Ingredient Data


Raw Label Data

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