SPL v1
SPL
SPL Set ID 90a9470f-f8c3-4fbc-9ff7-65f4bf843f65
Route
TOPICAL
Published
Effective Date 2021-03-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (14 mL)
Inactive Ingredients
Water Glycerin Aloe Vera Leaf Citrus Paradisi Seed Licorice Sandalwood

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2021-03-01

Description

Ethyl Alcohol 70.0%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 70.0%

Use[s]

Hand sanitizer to help reduce bacteria that potentially can cause disease.

For use when soap and water are not available.

Warnings

Warnings

For external use only

Flammable. Keep away from heat and flame, heat, sparks, and sources of static discharge

Do not use

■ In children less than 2 months of age

■ On open skin wounds

When using this product

■ Keep out of eyes, ears and mouth.

■ In case of contact with eyes, rinse thoroughly with water

Stop use and ask a doctor if 

■ irritation or rash occurs. These may be signs of a serious condition.

Directions

Spray a small amount of product into palm of hand.

Rub thoroughly over all surfaces of both hands

Rub hands together briskly until dry

Active Ingredient

Ethyl Alcohol 70.0%

Ndc: 74923 130 01

Ndc: 74923 130 02

Ndc: 74923 130 03

Other Information

■ Store between 15-30C(59-86F)

■ Avoid freezing and excessive heat above 40C(104F)

■ Store container in cool dry location, away from direct sunlight

Inactive Ingredients

Glycerin, Aloe Vera Extract, Purified Water USP, Grapefruit Seed Extract, Licorice Extract, Rose Water, Cassis Extract, Cedar Texas Oil, Sandalwood Extract

Keep Out of Reach of Children

Keep out of reach of children:

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

Supervise children under 6 years of age when using this product to avoid swallowing


Structured Label Content

Use[s]

Hand sanitizer to help reduce bacteria that potentially can cause disease.

For use when soap and water are not available.

Purpose (PURPOSE)

Antiseptic

Warnings (WARNINGS)

Warnings

For external use only

Flammable. Keep away from heat and flame, heat, sparks, and sources of static discharge

Do not use

■ In children less than 2 months of age

■ On open skin wounds

When using this product

■ Keep out of eyes, ears and mouth.

■ In case of contact with eyes, rinse thoroughly with water

Stop use and ask a doctor if 

■ irritation or rash occurs. These may be signs of a serious condition.

Directions

Spray a small amount of product into palm of hand.

Rub thoroughly over all surfaces of both hands

Rub hands together briskly until dry

Active Ingredient (ACTIVE INGREDIENT)

Ethyl Alcohol 70.0%

Ndc: 74923 130 01 (NDC: 74923-130-01)

Ndc: 74923 130 02 (NDC: 74923-130-02)

Ndc: 74923 130 03 (NDC: 74923-130-03)

Other Information

■ Store between 15-30C(59-86F)

■ Avoid freezing and excessive heat above 40C(104F)

■ Store container in cool dry location, away from direct sunlight

Inactive Ingredients (INACTIVE INGREDIENTS)

Glycerin, Aloe Vera Extract, Purified Water USP, Grapefruit Seed Extract, Licorice Extract, Rose Water, Cassis Extract, Cedar Texas Oil, Sandalwood Extract

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

Keep out of reach of children:

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

Supervise children under 6 years of age when using this product to avoid swallowing


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)