G0abhw07

G0abhw07
SPL v1
SPL
SPL Set ID 85f050b4-5abe-4e18-af83-d19b68e8a248
Route
TOPICAL
Published
Effective Date 2020-06-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 g)
Inactive Ingredients
Cocamidopropyl Betaine Peg-150 Distearate Benzyl Alcohol Phenoxyethanol Water Sodium Hydroxide Benzoic Acid .alpha.-tocopherol Acetate Verbena Officinalis Fd&c Red No. 4 Fd&c Yellow No. 5

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-06-30

Description

Benzalkonium Chloride 0.13%

Purpose

Antibacterial


Medication Information

Purpose

Antibacterial

Description

Benzalkonium Chloride 0.13%

Use

■ For hand washing to decrease bacteria on hands

Section 51945-4

Warnings

For external use only - hands

Directions

Apply a small amount to hands. Lather for at least 20 seconds then rinse with warm water

Avoid contact with eyes

Not recommended for infants

Active Ingredient

Benzalkonium Chloride 0.13%

Other Information

Do not store above 105F

May discolor some fabrics

Harmful to wood finishes and plastics

Inactive Ingredients

Water, Cocamidopropyl Betaine, PEG-150 Distearate, Cocamide MEA, Benzyl Alcohol, Fragrance, Phenoxyethanol, Sodium

Hydroxide, Tocopheryl Acetate, Benzoic Acid, Citrus Aurantium Bergamia (Bergamot) Fruit Extract, Verbena Officinalis Extract, Yellow 5, Red 4

When Using This Product

Keep out of eyes. In case of contact with eyes, flush thoroughly with water

Stop use and ask a doctor if skin irritation develops. 

Keep Out of Reach of Children

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a poison control center immediately


Structured Label Content

Use

■ For hand washing to decrease bacteria on hands

Section 51945-4 (51945-4)

Purpose

Antibacterial

Warnings (WARNINGS)

For external use only - hands

Directions

Apply a small amount to hands. Lather for at least 20 seconds then rinse with warm water

Avoid contact with eyes

Not recommended for infants

Active Ingredient

Benzalkonium Chloride 0.13%

Other Information

Do not store above 105F

May discolor some fabrics

Harmful to wood finishes and plastics

Inactive Ingredients (Inactive ingredients)

Water, Cocamidopropyl Betaine, PEG-150 Distearate, Cocamide MEA, Benzyl Alcohol, Fragrance, Phenoxyethanol, Sodium

Hydroxide, Tocopheryl Acetate, Benzoic Acid, Citrus Aurantium Bergamia (Bergamot) Fruit Extract, Verbena Officinalis Extract, Yellow 5, Red 4

When Using This Product (When Using this Product)

Keep out of eyes. In case of contact with eyes, flush thoroughly with water

Stop use and ask a doctor if skin irritation develops. 

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

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a poison control center immediately


Advanced Ingredient Data


Raw Label Data

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