77878-019, Style: Wp0017, Lemon Scent

77878-019, Style: Wp0017, Lemon Scent
SPL v1
SPL
SPL Set ID 6b862a9c-39f3-40d6-8bfb-8b8fe1f17f66
Route
TOPICAL
Published
Effective Date 2020-12-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (6.75 mg)
Inactive Ingredients
Water Aloe Vera Leaf Polysorbate 20 Propylene Glycol Phenoxyethanol .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-12-18

Description

Benzalkonium Chloride  0.13%

Purpose

Antibacterial


Medication Information

Purpose

Antibacterial

Description

Benzalkonium Chloride  0.13%

Use

To decrease bacteria on the skin that could cause disease

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if irritation and redness develop, condition persists for more than 72 hours

Section 50567-7

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

Avoid contact with broken skin

Section 51945-4

Warnings

For external use only

Directions

Wet hands thoroughly with product and allow to dry without wiping

For children under 6, use only under adult supervision

Not recommended for infants

Other Information
  • Keep containers tightly closed in a dry, cool and well ventilated place
  • Recommended storage temperature: 32F to 104F (0C to 40C)
Active Ingredient(s)

Benzalkonium Chloride  0.13%

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Fragrance, Phenoxyethanol, Polysorbate 20, Propylene Glycol, Tocopheryl Acetate, Water


Structured Label Content

Use

To decrease bacteria on the skin that could cause disease

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation and redness develop, condition persists for more than 72 hours

Section 50567-7 (50567-7)

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

Avoid contact with broken skin

Section 51945-4 (51945-4)

Purpose

Antibacterial

Warnings

For external use only

Directions

Wet hands thoroughly with product and allow to dry without wiping

For children under 6, use only under adult supervision

Not recommended for infants

Other Information (Other information)
  • Keep containers tightly closed in a dry, cool and well ventilated place
  • Recommended storage temperature: 32F to 104F (0C to 40C)
Active Ingredient(s)

Benzalkonium Chloride  0.13%

Inactive Ingredients (Inactive ingredients)

Aloe Barbadensis Leaf Juice, Fragrance, Phenoxyethanol, Polysorbate 20, Propylene Glycol, Tocopheryl Acetate, Water


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)