SPL v2
SPL
SPL Set ID b4697319-437e-2ec8-e053-2a95a90abb56
Route
TOPICAL
Published
Effective Date 2021-10-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (1 mg)
Inactive Ingredients
Lactic Acid Carbomer Homopolymer, Unspecified Type Water Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2021-10-05

Description

Benzalkonium chloride 0.1%


Medication Information

Warnings and Precautions

For external use only

Description

Benzalkonium chloride 0.1%

Uses

For hand sanitizing to decrease bacteria on the skin.

Recommended for repeated use.

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 or redness develops, or if condition persists for more than 72 hours.

Section 50567-7

When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

Section 51727-6

Water, carbomer, glycerin, lactic acid.

Section 51945-4

74146-244-02

Section 55105-1

Antimicrobial

Section 55106-9

Benzalkonium chloride 0.1%

Directions
  • Pump a small amount of gel into pal of hand
  • Rub thoroughly over all surfaces of both hands
  • Rub hands together briskly until dry.

Structured Label Content

Uses

For hand sanitizing to decrease bacteria on the skin.

Recommended for repeated use.

Warnings and Precautions (34071-1)

For external use only

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 or redness develops, or if condition persists for more than 72 hours.

Section 50567-7 (50567-7)

When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

Section 51727-6 (51727-6)

Water, carbomer, glycerin, lactic acid.

Section 51945-4 (51945-4)

74146-244-02

Section 55105-1 (55105-1)

Antimicrobial

Section 55106-9 (55106-9)

Benzalkonium chloride 0.1%

Directions
  • Pump a small amount of gel into pal of hand
  • Rub thoroughly over all surfaces of both hands
  • Rub hands together briskly until dry.

Advanced Ingredient Data


Raw Label Data

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