SPL v2
SPL
SPL Set ID aca60fcf-ee95-d924-e053-2995a90a3a3f
Route
TOPICAL
Published
Effective Date 2020-08-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (25 g)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-08-12

Description

Ethyl Alcohol 75% v/v, Antiseptic

Purpose

Antiseptic, Hand Sanitizer


Medication Information

Purpose

Antiseptic, Hand Sanitizer

Description

Ethyl Alcohol 75% v/v, Antiseptic

Use

For handwashing to decrease bacteria on the skin.

Section 50565-1

Keep out of reach of children. Supervise children under 6 years of age when using this product to avoid swallowing.

Section 50566-9

Stop use and ask a doctor if irritation or rash develops and continues for more than 72 hours.

Section 50567-7

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 rash occurs. These may be signs of a serious condition.







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

Warnings

For external use only. Flammable. Keep away from heat or flame.

Directions
  • Tear open packet, remove and unfold pre-moistened tissue.
  • Wipe hands including nails and cuticles.
  • Allow to dry without wiping.
  • Discard properly after use.​
Do Not Use
  • in children less than 2 months of age
  • on open skin wounds
Other Information
  • Store at room temperature.
  • Avoid freezing and excessive heat above 40˚C (104˚F)
Active Ingredient(s)

Ethyl Alcohol 75% v/v, Antiseptic

Inactive Ingredients

Aqua(Water).

Package Label Principal Display Panel

80 Wipes in 1 Pail NDC: 79621-628-01


Structured Label Content

Use

For handwashing to decrease bacteria on the skin.

Section 50565-1 (50565-1)

Keep out of reach of children. Supervise children under 6 years of age when using this product to avoid swallowing.

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation or rash develops and continues for more than 72 hours.

Section 50567-7 (50567-7)

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 rash occurs. These may be signs of a serious condition.







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

Purpose

Antiseptic, Hand Sanitizer

Warnings

For external use only. Flammable. Keep away from heat or flame.

Directions
  • Tear open packet, remove and unfold pre-moistened tissue.
  • Wipe hands including nails and cuticles.
  • Allow to dry without wiping.
  • Discard properly after use.​
Do Not Use (Do not use)
  • in children less than 2 months of age
  • on open skin wounds
Other Information (Other information)
  • Store at room temperature.
  • Avoid freezing and excessive heat above 40˚C (104˚F)
Active Ingredient(s)

Ethyl Alcohol 75% v/v, Antiseptic

Inactive Ingredients (Inactive ingredients)

Aqua(Water).

Package Label Principal Display Panel (Package Label - Principal Display Panel)

80 Wipes in 1 Pail NDC: 79621-628-01


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)