SPL v1
SPL
SPL Set ID adf54ef2-bbfe-53dc-e053-2a95a90a1594
Route
TOPICAL
Published
Effective Date 2020-09-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 g)
Inactive Ingredients
Water Propylene Glycol Ethylhexylglycerin Phenoxyethanol Glycerin Didecyldimonium Chloride

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-08-28

Description

Recommended for repeated use.


Medication Information

Warnings and Precautions

For external use only. Do not use over large areas of the body or if you are allergic to any of these ingredients.

When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

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

Keep out of reach of children.

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

Indications and Usage

Lift tab at front of the lid t o open.

Pull up corner of center sheet and thread

through di spenser slit i n the l id.

Pull up exposed wipe and snap off.

The next wipe i s ready for dispensing.

Close lid t o retain moisture.

Take wipe and rub thoroughly over all

surfaces of bot h hands. Rub hands briskly

together to dry.

Dispose of used wipe in trash.

Dosage and Administration

Recommended for repeated use.

Description

Recommended for repeated use.

Section 50565-1

Keep out of reach of children.

Section 51727-6

Water, Phenoxyethanol, Ethylhexylglycerin, Didecyldimonium Chloride , Propylene Glycol, Glycerin

Section 51945-4

Section 55105-1

For Hand Sanitizing to decrease bacteria on the skin. Recommended for repeated use.

Section 55106-9

Benzalkonium Chloride


Structured Label Content

Indications and Usage (34067-9)

Lift tab at front of the lid t o open.

Pull up corner of center sheet and thread

through di spenser slit i n the l id.

Pull up exposed wipe and snap off.

The next wipe i s ready for dispensing.

Close lid t o retain moisture.

Take wipe and rub thoroughly over all

surfaces of bot h hands. Rub hands briskly

together to dry.

Dispose of used wipe in trash.

Dosage and Administration (34068-7)

Recommended for repeated use.

Warnings and Precautions (34071-1)

For external use only. Do not use over large areas of the body or if you are allergic to any of these ingredients.

When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

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

Keep out of reach of children.

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

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51727-6 (51727-6)

Water, Phenoxyethanol, Ethylhexylglycerin, Didecyldimonium Chloride , Propylene Glycol, Glycerin

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

For Hand Sanitizing to decrease bacteria on the skin. Recommended for repeated use.

Section 55106-9 (55106-9)

Benzalkonium Chloride


Advanced Ingredient Data


Raw Label Data

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