first line alcohol wipes

first line alcohol wipes
SPL v1
SPL
SPL Set ID b3eddf05-d339-faac-e053-2a95a90a81d5
Route
topical
Published
Effective Date 2020-11-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (0.75 mL)
Inactive Ingredients
water glycerin

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2020-10-01

Purpose

Antiseptic

Description

Ethyl alcohol 75% v/v


Medication Information

Warnings

Flammable. Keep away from fire or flame.

For external use only.

Purpose

Antiseptic

Directions
  • Wet hands thoroughly with product and allow to dry.
  • Children under 6 years of age should be supervised.
Other Information
  • Store between 15°-30°C (59°-86°F)
  • Avoid freezing and excessive heat over 40°C (104°F)
  • Protect from direct sunlight. Keep container sealed.
  • May discolor certain fabrics or surfaces.
Inactive Ingredients

water, glycerin

Description

Ethyl alcohol 75% v/v

Use
  • Topical antiseptic
  • Recommended for repeated use
Do Not Use
  • in children less than 2 months in age
  • on open skin wounds
Active Ingredient

Ethyl alcohol 75% v/v

Package Labeling:

When Using This Product

keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop Use and Ask A Doctor

if irritation or redness develops and lasts more than 72 hours

Keep Out of Reach of Children.

If swallowed, seek medical help or contact a Poison Control Center right away.


Structured Label Content

Warnings

Flammable. Keep away from fire or flame.

For external use only.

Purpose

Antiseptic

Directions
  • Wet hands thoroughly with product and allow to dry.
  • Children under 6 years of age should be supervised.
Other Information (Other information)
  • Store between 15°-30°C (59°-86°F)
  • Avoid freezing and excessive heat over 40°C (104°F)
  • Protect from direct sunlight. Keep container sealed.
  • May discolor certain fabrics or surfaces.
Inactive Ingredients (Inactive ingredients)

water, glycerin

Use
  • Topical antiseptic
  • Recommended for repeated use
Do Not Use (Do not use)
  • in children less than 2 months in age
  • on open skin wounds
Active Ingredient (Active ingredient)

Ethyl alcohol 75% v/v

Package Labeling:

When Using This Product (When using this product)

keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if irritation or redness develops and lasts more than 72 hours

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, seek medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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