50563-334/jas21f15

50563-334/jas21f15
SPL v1
SPL
SPL Set ID 04a56adc-3e8e-466c-bc30-892d8fc1d8d3
Route
TOPICAL
Published
Effective Date 2020-10-11
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 Blue No. 1 Fd&c Yellow No. 5

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-10-11

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 palms 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, PEG 100 Stearate,  Glycerin, C13-14 Isoparaffin, Laureth-7, Polyacrylamide, Phenoxyethanol, Benzyl Alcohol, Fragrance (Parfum), Butyrospermum Parkii (Shea) Butter, Citric Acid, Tocopheryl Acetate, Blue 1, Yellow 5


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 palms 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, PEG 100 Stearate,  Glycerin, C13-14 Isoparaffin, Laureth-7, Polyacrylamide, Phenoxyethanol, Benzyl Alcohol, Fragrance (Parfum), Butyrospermum Parkii (Shea) Butter, Citric Acid, Tocopheryl Acetate, Blue 1, Yellow 5


Advanced Ingredient Data


Raw Label Data

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