SPL v2
SPL
SPL Set ID ab02746d-d329-3869-e053-2a95a90a5eff
Route
TOPICAL
Published
Effective Date 2020-07-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.65 g)
Inactive Ingredients
Water Glycerin Methylparaben Propylene Glycol Phenoxyethanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-07-22

Description

Do not store above 110°F(43° C).


Medication Information

Warnings and Precautions

1.Keep away from children.

2.For external use only.

3.Keep out of eyes. If contacts eyes, flush with water and call a doctor.

4.If irritation or rash: appears and persists, stops use and see a physician.

5.Do not store above 110°F(43° C)

6.If swallowed, get medical help or contact a Poison Control Center right away.

Indications and Usage

Place enough product on hands to cover all surfaces. Rub hands together until dry. No rinsing required.

Dosage and Administration

Do not store above 110°F(43° C).

Description

Do not store above 110°F(43° C).

Section 50565-1

keep out of reach of children

Section 51727-6

Deionized Water,Glycerin,Propylene Glycol,Methylparaben, Phenoxyethanol

Section 51945-4

Section 55105-1

Disinfection

Sterilization

No Rinseing

Section 55106-9

Benzalkonium Chloride


Structured Label Content

Indications and Usage (34067-9)

Place enough product on hands to cover all surfaces. Rub hands together until dry. No rinsing required.

Dosage and Administration (34068-7)

Do not store above 110°F(43° C).

Warnings and Precautions (34071-1)

1.Keep away from children.

2.For external use only.

3.Keep out of eyes. If contacts eyes, flush with water and call a doctor.

4.If irritation or rash: appears and persists, stops use and see a physician.

5.Do not store above 110°F(43° C)

6.If swallowed, get medical help or contact a Poison Control Center right away.

Section 50565-1 (50565-1)

keep out of reach of children

Section 51727-6 (51727-6)

Deionized Water,Glycerin,Propylene Glycol,Methylparaben, Phenoxyethanol

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Disinfection

Sterilization

No Rinseing

Section 55106-9 (55106-9)

Benzalkonium Chloride


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)