SPL v1
SPL
SPL Set ID a3f1ab03-6945-9827-e053-2995a90a625f
Route
TOPICAL
Published
Effective Date 2020-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (75 mL)
Inactive Ingredients
Citral Tea Tree Oil Limonene, (+)- Litsea Oil Bitter Orange Oil Lemon Oil, Terpeneless Water

Identifiers & Packaging

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

Description

Alcohol 80% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer


Medication Information

Purpose

Antiseptic, Hand Sanitizer

Description

Alcohol 80% v/v. Purpose: Antiseptic

Use

to help reduce bacteria on the skin

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

Spray on palm, rub together until dry. Supervise children under 6.

Do Not Use

near eyes. In case of contact, rinse eyes thoroughly with water.

Other Information

Do not store above 104°F (40°C)。Avoid placing under direct sun.

Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic

Inactive Ingredients

Water (Aqua), Bitter Orange (Citrus aurantium amara) peel oil*, Tea tree (Melaleuca Alternifolia) leaf oil*, May Chang (Litsea cubeba) fruit oil*, Limonene, Citral.

Package Label Principal Display Panel


Structured Label Content

Use

to help reduce bacteria on the skin

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

Spray on palm, rub together until dry. Supervise children under 6.

Do Not Use (Do not use)

near eyes. In case of contact, rinse eyes thoroughly with water.

Other Information (Other information)

Do not store above 104°F (40°C)。Avoid placing under direct sun.

Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic

Inactive Ingredients (Inactive ingredients)

Water (Aqua), Bitter Orange (Citrus aurantium amara) peel oil*, Tea tree (Melaleuca Alternifolia) leaf oil*, May Chang (Litsea cubeba) fruit oil*, Limonene, Citral.

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


Advanced Ingredient Data


Raw Label Data

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