SPL v2
SPL
SPL Set ID ae4556b5-d778-558a-e053-2a95a90ae1b1
Route
TOPICAL
Published
Effective Date 2020-09-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.125 mg)
Inactive Ingredients
Alpha-tocopherol Acetate Edetate Sodium Water Methylchloroisothiazolinone/methylisothiazolinone Mixture Aloe Vera Leaf Citric Acid Monohydrate Fragrance Clean Orc0600327 Polysorbate 20 Sodium Cocoamphoacetate Propylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-09-01

Description

Antibacterial


Medication Information

Warnings and Precautions

For external use only.

Indications and Usage

Hand sanitizer to help reduce bacteria on the skin

Dosage and Administration

Topical admistration

Description

Antibacterial

Section 50565-1

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

Section 50566-9

If irritation or rash develops and continues for more than 72 hours

Section 50567-7

Do not get into eyes.

If contact occurs, rinse throughly with water

Section 50569-3

If irritation or rash develops and continues for more than 72 hours

Section 50570-1

If you are allergic to any of the ingredients

Section 51727-6

water, propylene glycol USP, polysorbate 20, sodium cocoamphoacetate, fragrance, methylchloroisothiazolinone / methylisothiazolinone, aloe vera extract, tetrasodium EDTA, citric acid, acetate D alpha- tocopherol

Section 51945-4

Section 55105-1

Antibacterial

Section 55106-9

BENZALKONIUM, CHLORIDE 0.125%

Section 59845-8

- wet hands throughly with product and allow to dry.

-discard wipe in trash receptacle after use. Do not flush

- chuldren under 6 years af age should be supervised whe using this product


Structured Label Content

Indications and Usage (34067-9)

Hand sanitizer to help reduce bacteria on the skin

Dosage and Administration (34068-7)

Topical admistration

Warnings and Precautions (34071-1)

For external use only.

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

If irritation or rash develops and continues for more than 72 hours

Section 50567-7 (50567-7)

Do not get into eyes.

If contact occurs, rinse throughly with water

Section 50569-3 (50569-3)

If irritation or rash develops and continues for more than 72 hours

Section 50570-1 (50570-1)

If you are allergic to any of the ingredients

Section 51727-6 (51727-6)

water, propylene glycol USP, polysorbate 20, sodium cocoamphoacetate, fragrance, methylchloroisothiazolinone / methylisothiazolinone, aloe vera extract, tetrasodium EDTA, citric acid, acetate D alpha- tocopherol

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antibacterial

Section 55106-9 (55106-9)

BENZALKONIUM, CHLORIDE 0.125%

Section 59845-8 (59845-8)

- wet hands throughly with product and allow to dry.

-discard wipe in trash receptacle after use. Do not flush

- chuldren under 6 years af age should be supervised whe using this product


Advanced Ingredient Data


Raw Label Data

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