SPL v1
SPL
SPL Set ID ac0a534c-dfed-67c6-e053-2995a90a6d3c
Route
TOPICAL
Published
Effective Date 2020-08-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (750 mL)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-08-05

Description

Drug Facts

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Drug Facts

Use

1.Hand Sanitizer to help decrease bacteria on the skin.

2.When water,soap & towel are not available.

3.Recommended for repeated use.

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. Children must be supervised in use of this product.

Section 50566-9

Stop use and ask a doctor if redness or irritation develop and persist for more than 72 hours.

Section 50567-7

When using this product avoid contact with eyes.In case of contact flush eyes with water.

Warnings

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

Directions

Tear off the package and pull out the cotton piece, wipe and disinfect the skin.

Do Not Use

Do not apply around eyes.

Do not use in ears & mouth.

Other Information

Store at 20C (88 to 77F) may discolor fabrices.

Active Ingredient(s)

Ethyl Alcohol 75%

Inactive Ingredients

Water, spunlaced nonwovens.

Package Label Principal Display Panel


Structured Label Content

Use

1.Hand Sanitizer to help decrease bacteria on the skin.

2.When water,soap & towel are not available.

3.Recommended for repeated use.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. Children must be supervised in use of this product.

Section 50566-9 (50566-9)

Stop use and ask a doctor if redness or irritation develop and persist for more than 72 hours.

Section 50567-7 (50567-7)

When using this product avoid contact with eyes.In case of contact flush eyes with water.

Purpose

Antiseptic

Warnings

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

Directions

Tear off the package and pull out the cotton piece, wipe and disinfect the skin.

Do Not Use (Do not use)

Do not apply around eyes.

Do not use in ears & mouth.

Other Information (Other information)

Store at 20C (88 to 77F) may discolor fabrices.

Active Ingredient(s)

Ethyl Alcohol 75%

Inactive Ingredients (Inactive ingredients)

Water, spunlaced nonwovens.

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)