Sanitizing Wipes

Sanitizing Wipes
SPL v4
SPL
SPL Set ID ad328c9a-e213-6944-e053-2995a90adfff
Route
TOPICAL
Published
Effective Date 2020-08-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (95.61 mg)
Inactive Ingredients
Water Aloe Vera Leaf Alpha-tocopherol Polihexanide Hydrochloride Alcohol Propylene Glycol Lemon Terpenes Phenoxyethanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-08-19

Description

Benzalkonium chloride 0.1%


Medication Information

Warnings and Precautions

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

Indications and Usage

Hand sanitizer to help reduce bacteria on the skin.

For use when soap and water are not available.

Dosage and Administration

Open packet, remove and unfold pre-moistened tissue. Wipe hands or affected area thoroughly, then discard properly after use. Reseal back after use to keep wipes fresh.

Description

Benzalkonium chloride 0.1%

Section 44425-7

Store between 15-30C (59-86F)

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

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.

Section 50570-1

in children less than 2 months of age

on open skin wounds

Section 51727-6

Phenoxy Ethanol, Polyhexamethylene Biguanide Hydrochloride, Purified Water, Propylene Glycol, Ethyl Alcohol, Vitamin E, Lemon Terpenes, Aloe Vera Extract.

Section 51945-4

10 wipes NDC: 80144-001-01

35 wipes NDC: 80144-001-02

Section 55105-1

Antiseptic, Hand Sanitizer

Section 55106-9

Benzalkonium chloride 0.1%


Structured Label Content

Indications and Usage (34067-9)

Hand sanitizer to help reduce bacteria on the skin.

For use when soap and water are not available.

Dosage and Administration (34068-7)

Open packet, remove and unfold pre-moistened tissue. Wipe hands or affected area thoroughly, then discard properly after use. Reseal back after use to keep wipes fresh.

Warnings and Precautions (34071-1)

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

Section 44425-7 (44425-7)

Store between 15-30C (59-86F)

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

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.

Section 50570-1 (50570-1)

in children less than 2 months of age

on open skin wounds

Section 51727-6 (51727-6)

Phenoxy Ethanol, Polyhexamethylene Biguanide Hydrochloride, Purified Water, Propylene Glycol, Ethyl Alcohol, Vitamin E, Lemon Terpenes, Aloe Vera Extract.

Section 51945-4 (51945-4)

10 wipes NDC: 80144-001-01

35 wipes NDC: 80144-001-02

Section 55105-1 (55105-1)

Antiseptic, Hand Sanitizer

Section 55106-9 (55106-9)

Benzalkonium chloride 0.1%


Advanced Ingredient Data


Raw Label Data

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