SPL v1
SPL
SPL Set ID cfc21b33-1a02-474c-a1ee-7a60a6ba5203
Route
TOPICAL
Published
Effective Date 2020-05-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (350 mL)
Inactive Ingredients
Water Glycerin Green Tea Leaf Lavender Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-05-01

Description

ALCOHOL 70% v/v

Purpose

Purpose: SANITIZER


Medication Information

Purpose

Purpose: SANITIZER

Description

ALCOHOL 70% v/v

Uses

•instant hand antiseptic to decrease bacteria on the skin

•recommended for repeated use

Warnings

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

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Do not use

• in children less than 2 months of age

• on open skin wounds

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When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

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

Questions

Questions

82.70.8882.5701

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.

Active Ingredient

ALCOHOL 70% v/v

Other Information

• Store between 15-30C (59-86F)

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

Inactive Ingredients

Water, Glycerin, Camellia Sinensis Leaf Extract, Lavandula Angustifolia (Lavender) Flower Water, Flavor

Keep Out of Reach of Children

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

Package Label.principal Display Panel


Structured Label Content

Uses

•instant hand antiseptic to decrease bacteria on the skin

•recommended for repeated use

Purpose (PURPOSE)

Purpose: SANITIZER

Warnings (WARNINGS)

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

--------------------------------------------------------------------------------------------------------

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 eyes thoroughly with water.

--------------------------------------------------------------------------------------------------------

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

Questions

Questions

82.70.8882.5701

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.

Active Ingredient (ACTIVE INGREDIENT)

ALCOHOL 70% v/v

Other Information

• Store between 15-30C (59-86F)

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

Inactive Ingredients (INACTIVE INGREDIENTS)

Water, Glycerin, Camellia Sinensis Leaf Extract, Lavandula Angustifolia (Lavender) Flower Water, Flavor

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.

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)


Advanced Ingredient Data


Raw Label Data

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