SPL v2
SPL
SPL Set ID a3115790-8c87-762e-e053-2995a90ae692
Route
TOPICAL
Published
Effective Date 2020-04-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Didecyldimonium (0.5 g) Benzalkonium (0.15 g) Polyaminopropyl Biguanide (1 g)
Inactive Ingredients
Glyceryl Caprylate Phenoxyethanol Hydroxyethyl Cellulose, Unspecified Propylene Glycol Glycerin Water Glyceryl Laurate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-04-12

Description

antimicrobial


Medication Information

Dosage and Administration

Store below 丨06°F.(41℃)

May discolor certain fabrics or surfaces

Description

antimicrobial

Uses

antimicrobial

Label

Section 50565-1

Children under 6years of age should be supervised when using this product.

Section 50567-7

When using this product, do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water. Stop use and ask doctor if irritation or rash appears and lasts.Keep out of reach for children.If swallowed, get medical help or contact a Poison Control Center right away.

Section 55106-9

2,3-DICHLORO-5,6-DICYANOBENZOQUINONE 0.15%

POLYAMINOPROPYL BIGUANIDE 1%

BENZALKONIUM CHLORIDE 0.15%

Warnings

Flammable.Keep away from fire or flame.

For external use only.

Directions

Place enough Product in your palm to thorouhjly spread on both hands and rub into the skin until dre.

Children under 6years of age should be supervised when using this product.

Other Information
  • Store below 丨06°F.(41℃)
  • May discolor certain fabrics or surfaces
Inactive Ingredients

WATER,GLYCERIN,PROPYLENE GLYCOL,

HYDROXYETHYLCELLULOSE,

HYDROGENATED CASTOR OIL


Structured Label Content

Uses

antimicrobial

Label

Dosage and Administration (34068-7)

Store below 丨06°F.(41℃)

May discolor certain fabrics or surfaces

Section 50565-1 (50565-1)

Children under 6years of age should be supervised when using this product.

Section 50567-7 (50567-7)

When using this product, do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water. Stop use and ask doctor if irritation or rash appears and lasts.Keep out of reach for children.If swallowed, get medical help or contact a Poison Control Center right away.

Section 55106-9 (55106-9)

2,3-DICHLORO-5,6-DICYANOBENZOQUINONE 0.15%

POLYAMINOPROPYL BIGUANIDE 1%

BENZALKONIUM CHLORIDE 0.15%

Warnings

Flammable.Keep away from fire or flame.

For external use only.

Directions

Place enough Product in your palm to thorouhjly spread on both hands and rub into the skin until dre.

Children under 6years of age should be supervised when using this product.

Other Information (Other information)
  • Store below 丨06°F.(41℃)
  • May discolor certain fabrics or surfaces
Inactive Ingredients (Inactive ingredients)

WATER,GLYCERIN,PROPYLENE GLYCOL,

HYDROXYETHYLCELLULOSE,

HYDROGENATED CASTOR OIL


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)