SPL v1
SPL
SPL Set ID aa843c84-1ec3-07e9-e053-2995a90a1945
Route
TOPICAL
Published
Effective Date 2020-07-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (62 mL)
Inactive Ingredients
Maltodextrin Aloe Vera Leaf Water Glycerin Propylene Glycol Carbomer Copolymer Type A (allyl Pentaerythritol Crosslinked) Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-07-15

Description

Ethyl alcohol 62%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Ethyl alcohol 62%

Uses
  • to decrease bacteria on the skin that could cause disease
  • recommended for repeated use
Section 51945-4

Warnings

For external use only: hands

Flammable. Keep away from heat and flame.

Directions
  • wet hands thoroughly with product and allow to dry without wiping
  • for children under 6, ues only under adult supervision
  • not recommended for infants

Other Information
  • do not store above 105F
  • may discolor some fabrics
  • harmful to wood finishes and plastics

Active Ingredient:

Ethyl alcohol 62%

Inactive Ingredients

water, glycerin, propylene glycol, acrylates/C10-C30 alkyl acrylate crosspolymer, triethanolamine, aloe barbadensis leaf juice, maltodextrin

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
Stop Use and Ask A Doctor If
  • irritation or redness develops
  • condition persists for more that 72 hours
Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center(1-800-222-1222) right away.


Structured Label Content

Uses
  • to decrease bacteria on the skin that could cause disease
  • recommended for repeated use
Section 51945-4 (51945-4)

Purpose

Antiseptic

Warnings

For external use only: hands

Flammable. Keep away from heat and flame.

Directions
  • wet hands thoroughly with product and allow to dry without wiping
  • for children under 6, ues only under adult supervision
  • not recommended for infants

Other Information
  • do not store above 105F
  • may discolor some fabrics
  • harmful to wood finishes and plastics

Active Ingredient: (Active ingredient:)

Ethyl alcohol 62%

Inactive Ingredients (Inactive ingredients)

water, glycerin, propylene glycol, acrylates/C10-C30 alkyl acrylate crosspolymer, triethanolamine, aloe barbadensis leaf juice, maltodextrin

When Using This Product (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
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • irritation or redness develops
  • condition persists for more that 72 hours
Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center(1-800-222-1222) right away.


Advanced Ingredient Data


Raw Label Data

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