SPL v2
SPL
SPL Set ID c42d6e01-1034-4cb0-9ece-672d392042f5
Route
TOPICAL
Published
Effective Date 2020-05-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Water Hydrogen Peroxide Glycerin 1,2,3-propanetriol, 2-(4-aminobenzoate)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-05-04

Description

Alcohol 70% v/v.

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Alcohol 70% v/v.

Uses

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

Section 42229-5

For external use only, do not drink.

Section 50565-1

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.

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.

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.

Other information

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Active Ingredient

Alcohol 70% v/v.

Inactive Ingredients

Polyethylene glycol,1, 2, 3-Propanetriol, 1 ,3-Propanediamine, Benzyl benzoate, D-Limonene, .alpha.-Pinene, Hydrogen peroxide, Octanal, 2- (phenylmethylene), Oils (Siberian Fir, Citral, Geraniol Oils, Lemon, Juniper, Ethanone, Oils, Coriander, Sweet Orange, Petitgrain, Citronella, Citronellol, Geranium, Eucalyptus, Mandarin, Lime, Camphor oil, Linalool, Cyclohexanone

Package Label Principal Display Panel


Structured Label Content

Uses

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)

For external use only, do not drink.

Section 50565-1 (50565-1)

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

Purpose

Antiseptic

Warnings

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

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.

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.

Other information

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Active Ingredient

Alcohol 70% v/v.

Inactive Ingredients (Inactive ingredients)

Polyethylene glycol,1, 2, 3-Propanetriol, 1 ,3-Propanediamine, Benzyl benzoate, D-Limonene, .alpha.-Pinene, Hydrogen peroxide, Octanal, 2- (phenylmethylene), Oils (Siberian Fir, Citral, Geraniol Oils, Lemon, Juniper, Ethanone, Oils, Coriander, Sweet Orange, Petitgrain, Citronella, Citronellol, Geranium, Eucalyptus, Mandarin, Lime, Camphor oil, Linalool, Cyclohexanone

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


Advanced Ingredient Data


Raw Label Data

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