50563-466/jas21xl2

50563-466/jas21xl2
SPL v1
SPL
SPL Set ID c8e5381c-bb0b-454a-8466-a19723a95196
Route
TOPICAL
Published
Effective Date 2021-07-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 g)
Inactive Ingredients
Mineral Oil Glyceryl Stearate Se Peg-100 Stearate C13-14 Isoparaffin Glycerin Water Polyacrylamide (1500 Mw) Laureth-7 Phenoxyethanol Benzyl Alcohol Benzoic Acid Citric Acid Monohydrate Butyrospermum Parkii (shea) Butter Unsaponifiables .alpha.-tocopherol Acetate Fd&c Red No. 4 Fd&c Yellow No. 5 Fd&c Blue No. 1 Cetostearyl Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2021-07-04

Description

Benzalkonium Chloride 0.13%

Purpose

Antibacterial


Medication Information

Purpose

Antibacterial

Description

Benzalkonium Chloride 0.13%

Use

■ To help reduce the bacteria on the skin

Section 50565-1

Keep out of reach of children. In case of accidenta ingestion, seek professional assistance or contact a Poison Control Center immdiately.

Section 50566-9

Stop use and ask a doctor if skin irritation develops.

Section 51945-4

Warnings

For external use only

When using this product, keep out of eyes. In case of contact with eyes, flush thoroughly with water.

Directions

Apply a small amount to palm and rub hands together thoroughly

Active Ingredient

Benzalkonium Chloride 0.13%

Other Information

Do not store above 105F

May doscolor some fabrics

Harmful to wood finishes and plastics

Inactive Ingredients

Water, Cetearyl Alcohol, Mineral Oil, Glyceryl Stearate, Glycerin, PEG-100 Stearate,  C13-14 Isoparaffin, Polyacrylamide, Laureth-7, Phenoxyethanol, Benzyl Alcohol, Benzoic Acid, Fragrance (Parfum), Citric Acid, Butyrospermum Parkii (Shea) Butter, Tocopheryl Acetate, Red 4, Yellow 5, Blue 1


Structured Label Content

Use

■ To help reduce the bacteria on the skin

Section 50565-1 (50565-1)

Keep out of reach of children. In case of accidenta ingestion, seek professional assistance or contact a Poison Control Center immdiately.

Section 50566-9 (50566-9)

Stop use and ask a doctor if skin irritation develops.

Section 51945-4 (51945-4)

Purpose

Antibacterial

Warnings (WARNINGS)

For external use only

When using this product, keep out of eyes. In case of contact with eyes, flush thoroughly with water.

Directions

Apply a small amount to palm and rub hands together thoroughly

Active Ingredient

Benzalkonium Chloride 0.13%

Other Information

Do not store above 105F

May doscolor some fabrics

Harmful to wood finishes and plastics

Inactive Ingredients (Inactive ingredients)

Water, Cetearyl Alcohol, Mineral Oil, Glyceryl Stearate, Glycerin, PEG-100 Stearate,  C13-14 Isoparaffin, Polyacrylamide, Laureth-7, Phenoxyethanol, Benzyl Alcohol, Benzoic Acid, Fragrance (Parfum), Citric Acid, Butyrospermum Parkii (Shea) Butter, Tocopheryl Acetate, Red 4, Yellow 5, Blue 1


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)