50563-338/jas21f19

50563-338/jas21f19
SPL v1
SPL
SPL Set ID 99a71c63-39de-443d-9f94-0d35283004cb
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

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2020-10-11

Purpose

Antibacterial

Description

Benzalkonium Chloride 0.13%


Medication Information

Warnings

For external use only

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

Purpose

Antibacterial

Directions

Apply a small amount to palms and rub hands together thoroughly

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

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

Active Ingredient

Benzalkonium Chloride 0.13%


Structured Label Content

Warnings (WARNINGS)

For external use only

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

Purpose

Antibacterial

Directions

Apply a small amount to palms and rub hands together thoroughly

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

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)

Active Ingredient

Benzalkonium Chloride 0.13%


Advanced Ingredient Data


Raw Label Data

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