SPL v2
SPL
SPL Set ID b01ac7fd-8b48-532e-e053-2995a90a6012
Route
TOPICAL
Published
Effective Date 2020-09-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Methylchloroisothiazolinone (0.02 g) Methylisothiazolinone (0.5 g) Bronopol (0.15 g) Benzalkonium (0.2 g)
Inactive Ingredients
Potassium Sorbate Propylene Glycol Polysorbate 20 Disodium Cocoamphodiacetate Aloe Vera Leaf Edetate Disodium .alpha.-tocopherol Acetate Citric Acid Monohydrate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Completed Since 2020-09-21 Until 2020-09-28

Description

Benzalkonium chloride 0.13%. Purpose: Antiseptic

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Benzalkonium chloride 0.13%. Purpose: Antiseptic

Uses

For sanitizing to decrease bacteria on skin

apply topically to the skin to help prevent cross contamination

recommended for repeated use

dries in seconds

Section 50565-1

Keep out of reach of children unless under adult supervision

Section 50566-9

Section 50567-7

Warnings

For external use only.

May irritate eyes

Keep out of reach of children unless under adult supervision

Active Ingredient(s)

Benzalkonium chloride 0.13%. Purpose: Antiseptic

Inactive Ingredients

Water, Propylene Glycol,Disodium EDTA,Chloro-methyl-isothiazolinone and Methyl-isothiazolinone,Potassium Sorbate,Quatermium-15,Aloe Barbadensis Leaf Juice,Disodium Cocoamphodiacetate,Vitamin E Acetate,Polysorbate-20,Citric Acid,Fragrance.

Package Label Principal Display Panel


Structured Label Content

Uses (USES)

For sanitizing to decrease bacteria on skin

apply topically to the skin to help prevent cross contamination

recommended for repeated use

dries in seconds

Section 50565-1 (50565-1)

Keep out of reach of children unless under adult supervision

Section 50566-9 (50566-9)

Section 50567-7 (50567-7)

Purpose

Antiseptic

Warnings

For external use only.

May irritate eyes

Keep out of reach of children unless under adult supervision

Active Ingredient(s)

Benzalkonium chloride 0.13%. Purpose: Antiseptic

Inactive Ingredients (Inactive ingredients)

Water, Propylene Glycol,Disodium EDTA,Chloro-methyl-isothiazolinone and Methyl-isothiazolinone,Potassium Sorbate,Quatermium-15,Aloe Barbadensis Leaf Juice,Disodium Cocoamphodiacetate,Vitamin E Acetate,Polysorbate-20,Citric Acid,Fragrance.

Package Label Principal Display Panel (Package Label - Principal Display Panel)


Advanced Ingredient Data


Raw Label Data

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