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

Active Ingredient

Benzalkonium chloride 0.1%

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


Structured Label Content

Warnings and Precautions (34071-1)

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

Active Ingredient (55106-9)

Benzalkonium chloride 0.1%

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.

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


Advanced Ingredient Data


Raw Label Data

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