SPL v1
SPL
SPL Set ID a41ef29a-0c00-f545-e053-2a95a90a3f67
Route
TOPICAL
Published
Effective Date 2020-05-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (100 mg)
Inactive Ingredients
Glycerin Sodium Benzoate Hydroxyacetophenone Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-05-12

Description

Benzalkonium Chloride 0.1%

Purpose

Antimicrobial


Medication Information

Purpose

Antimicrobial

Description

Benzalkonium Chloride 0.1%

Use[s]

eliminates harmful germs and bacteria on skin

Warnings.

For external use only.

Directions

Unfold towelette; Wipe hands; Discard after use

Do Not Use

if you are allergic to any of the ingredients

Package Label

Active Ingredient[s]

Benzalkonium Chloride 0.1%

Inactive Ingredients

Water, Glycerin, Sodium Benzoate, Hydroxyacetophenone

When Using This Product

do not get into eyes

Stop Use and Ask A Doctor

if irritation or rash appears and lasts

Keep Out of Reach of Children.

If swallowed, get medical help


Structured Label Content

Use[s]

eliminates harmful germs and bacteria on skin

Purpose

Antimicrobial

Warnings.

For external use only.

Directions

Unfold towelette; Wipe hands; Discard after use

Do Not Use (Do not use)

if you are allergic to any of the ingredients

Package Label

Active Ingredient[s] (Active ingredient[s])

Benzalkonium Chloride 0.1%

Inactive Ingredients (Inactive ingredients)

Water, Glycerin, Sodium Benzoate, Hydroxyacetophenone

When Using This Product (When using this product)

do not get into eyes

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if irritation or rash appears and lasts

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help


Advanced Ingredient Data


Raw Label Data

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