SPL v1
SPL
SPL Set ID c078ec88-b1b0-13c1-e053-2a95a90ad0e8
Route
TOPICAL
Published
Effective Date 2021-04-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.54 g)
Inactive Ingredients
Didecyldimonium Chloride Lemon Aloe Vera Leaf Glycerin Water Phenoxyethanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2021-04-21

Description

Store below 110°F (43°C)


Medication Information

Warnings and Precautions

For external use only.Flammable,keep away from heat or flame.

Description

Store below 110°F (43°C)

Use

Wipe on skin to help reduce bacteria on skin that potentially can cause disease.

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if iritation or rash occurs.These may be signs of a serious condition.

Section 50567-7

When using this product keep out of eyes, ears,and mouth.in case of contact witheyes, rinse eyes thorougly with water

Section 50570-1

On childiren less than 2 months of age

Section 51727-6

Glycerol

Aloe vera extract

Pure water

Didecyldimonium chloride

Phenoxyethanol

Lemon extract

Section 51945-4

Section 55105-1

Antiseptic

Section 55106-9

Benzalkonium chloride

Directions

Rub hands on wipe,and use to disnfect.

Supervise children under 6 years of age when using this product.

Other Information

Store below 110°F (43°C)


Structured Label Content

Use

Wipe on skin to help reduce bacteria on skin that potentially can cause disease.

Warnings and Precautions (34071-1)

For external use only.Flammable,keep away from heat or flame.

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if iritation or rash occurs.These may be signs of a serious condition.

Section 50567-7 (50567-7)

When using this product keep out of eyes, ears,and mouth.in case of contact witheyes, rinse eyes thorougly with water

Section 50570-1 (50570-1)

On childiren less than 2 months of age

Section 51727-6 (51727-6)

Glycerol

Aloe vera extract

Pure water

Didecyldimonium chloride

Phenoxyethanol

Lemon extract

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antiseptic

Section 55106-9 (55106-9)

Benzalkonium chloride

Directions

Rub hands on wipe,and use to disnfect.

Supervise children under 6 years of age when using this product.

Other Information (Other information)

Store below 110°F (43°C)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)