Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID aec7ba7f-e7e4-4773-e053-2995a90a67ae
Route
TOPICAL
Published
Effective Date 2020-09-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.0054 g)
Inactive Ingredients
Water Citric Acid Monohydrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-09-08

Description

Benzalkonium Chloride

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Benzalkonium Chloride

Uses

Hand sanitizing wipes to help reduce bacteria that potentially can cause disease.

Section 51945-4

Warnings

For external use only.

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Do not use

■ in children less than 2 months of age

■ on open skin wounds

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When using this product

■ avoid getting into the eyes (if contact occurs, wash well with clean water)

--------------------------------------------------------------------------------------------------------

Stop use and ask a doctor

■ hypersensitivity symptoms such as erythema, itching and dermatitis happen

■ skin irritation happens

Directions

■ Wet hands thoroughly with product and allow to dry without wiping

■ Do not flush

■ Children under 2 years ask a doctor before use

Active Ingredient

Benzalkonium Chloride

Other Information

■ Read the directions and warnings before use

■ Store between 15-30℃(59-89℉)

■ Avoid freezing and excessive heat above 40℃(104 ℉)

Inactive Ingredients

Water, Citric Acid

Keep Out of Reach of Children

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


Structured Label Content

Uses

Hand sanitizing wipes to help reduce bacteria that potentially can cause disease.

Section 51945-4 (51945-4)

Purpose (PURPOSE)

Antiseptic

Warnings (WARNINGS)

For external use only.

--------------------------------------------------------------------------------------------------------

Do not use

■ in children less than 2 months of age

■ on open skin wounds

--------------------------------------------------------------------------------------------------------

When using this product

■ avoid getting into the eyes (if contact occurs, wash well with clean water)

--------------------------------------------------------------------------------------------------------

Stop use and ask a doctor

■ hypersensitivity symptoms such as erythema, itching and dermatitis happen

■ skin irritation happens

Directions

■ Wet hands thoroughly with product and allow to dry without wiping

■ Do not flush

■ Children under 2 years ask a doctor before use

Active Ingredient (ACTIVE INGREDIENT)

Benzalkonium Chloride

Other Information (Other information)

■ Read the directions and warnings before use

■ Store between 15-30℃(59-89℉)

■ Avoid freezing and excessive heat above 40℃(104 ℉)

Inactive Ingredients (INACTIVE INGREDIENTS)

Water, Citric Acid

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)