SPL v1
SPL
SPL Set ID 671c5c57-b468-4574-9dbe-5bfd7c48bd15
Route
TOPICAL
Published
Effective Date 2020-08-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 g)
Inactive Ingredients
Water Phenoxyethanol Ethylhexylglycerin Propylene Glycol Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-08-13

Description

DRUG FACTS

Purpose

Antiseptic


Medication Information

Warnings and Precautions

Warnings

Purpose

Antiseptic

Description

DRUG FACTS

Uses:
  • Sanitizing wipe to help reduce bacteria that potentially can cause disease.
  • For use when soap and water are not available.
  • Safe for repeated use.
Section 42229-5

DRUG FACTS

Section 50570-1

For external use only.

When using this product avoid contact with eyes. If contact occurs, flush thoroughly with water. 

Discontinue use if  irritation or redness develops. If condition persists for more than 72 hours contact a doctor.

Do not use as a diaper wipe

Section 51945-4

Directions
  • Cover all surfaces thoroughlly with wipe and allow to dry naturally. Supervise children.
Active Ingredient

Benzalkonium Chloride .......... 0.13 %

Inactive Ingredients:

Phenoxyethanol, Ethylhexylglycerin, Didecyldimonium Chloride, Propylene Glycol, Glycerin, Purified Water, Lemon Fragrance

Keep Out of Reach of Children.

if swallowed get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses:
  • Sanitizing wipe to help reduce bacteria that potentially can cause disease.
  • For use when soap and water are not available.
  • Safe for repeated use.
Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

DRUG FACTS

Section 50570-1 (50570-1)

For external use only.

When using this product avoid contact with eyes. If contact occurs, flush thoroughly with water. 

Discontinue use if  irritation or redness develops. If condition persists for more than 72 hours contact a doctor.

Do not use as a diaper wipe

Section 51945-4 (51945-4)

Purpose

Antiseptic

Directions
  • Cover all surfaces thoroughlly with wipe and allow to dry naturally. Supervise children.
Active Ingredient

Benzalkonium Chloride .......... 0.13 %

Inactive Ingredients:

Phenoxyethanol, Ethylhexylglycerin, Didecyldimonium Chloride, Propylene Glycol, Glycerin, Purified Water, Lemon Fragrance

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

if swallowed get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)