SPL v2
SPL
SPL Set ID a421d60f-de67-5e3d-e053-2995a90a6fd1
Route
TOPICAL
Published
Effective Date 2020-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (4.72 mL)
Inactive Ingredients
Polyethylene Glycol 400 Water O-ethylvanillin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-03-30

Description

Alcohol (ethanol) (80%, volume/volume (v/v)) i Glycol (4.0% v/v). Fragrance (0.0% v/v). Sterile distilled water or boiled cold water.

Purpose

Antiseptic, Hand Sanitizer


Medication Information

Purpose

Antiseptic, Hand Sanitizer

Description

Alcohol (ethanol) (80%, volume/volume (v/v)) i Glycol (4.0% v/v). Fragrance (0.0% v/v). Sterile distilled water or boiled cold water.

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Section 42229-5
  • Alcohol (ethanol) (80%, volume/volume (v/v)) i
  • Glycol (4.0% v/v).
  • Fragrance (0.0% v/v).
  • Sterile distilled water or boiled cold water.

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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
  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.
Do Not Use
  • in children less than 2 months of age
  • on open skin wounds
Other Information
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic

Inactive Ingredients

glycol, fragrance, purified water USP

Package Label Principal Display Panel

118 mL NDC: 73829-106-04


Structured Label Content

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Section 42229-5 (42229-5)
  • Alcohol (ethanol) (80%, volume/volume (v/v)) i
  • Glycol (4.0% v/v).
  • Fragrance (0.0% v/v).
  • Sterile distilled water or boiled cold water.

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 50566-9 (50566-9)

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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
  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.
Do Not Use (Do not use)
  • in children less than 2 months of age
  • on open skin wounds
Other Information (Other information)
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic

Inactive Ingredients (Inactive ingredients)

glycol, fragrance, purified water USP

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

118 mL NDC: 73829-106-04


Advanced Ingredient Data


Raw Label Data

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