72c8e13f-393b-4ec6-be97-7bcae58c2354

SPL v1
SPL
SPL Set ID 72c8e13f-393b-4ec6-be97-7bcae58c2354
Route
topical
Published
Effective Date 2013-09-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
triclosan (1.5 mg)
Inactive Ingredients
water sodium c14-16 olefin sulfonate sodium laureth sulfate coco diethanolamide sodium chloride peg-150 distearate citric acid monohydrate glycerin edetate disodium .alpha.-tocopherol acetate methylchloroisothiazolinone fd&c yellow no. 5 methylisothiazolinone

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2013-09-17

Description

Active Ingredient                                   Purpose Triclosan 0.15%..................................Antibacterial


Medication Information

Warnings and Precautions

Warnings

For external use only.

Avoid getting into eyes. If this happens, rinse thoroughly with water.

Active Ingredient

Active Ingredient                                   Purpose

Triclosan 0.15%..................................Antibacterial

Indications and Usage

Wet hand, apply to hands, scrub thoroughly, Rinse.

Dosage and Administration

Wet hand, apply palmful to hands, scrub thoroughly, Rinse.

Description

Active Ingredient                                   Purpose Triclosan 0.15%..................................Antibacterial

Section 50565-1

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

Section 51727-6

Inactive Ingredients

camphor, carbomer, ethyl alcohol, fd&c blue no.1, isopropyl alcohol, methylchloroisothiazolinone, methylisothiazolinone, sodium hydroxide, water, cocamide MEA, PEG-18 glycaryl

Section 51945-4

Section 55105-1

Uses

for handwashing to decrease bacteria on the skin.


Structured Label Content

Warnings and Precautions (34071-1)

Warnings

For external use only.

Avoid getting into eyes. If this happens, rinse thoroughly with water.

Active Ingredient (55106-9)

Active Ingredient                                   Purpose

Triclosan 0.15%..................................Antibacterial

Indications and Usage (34067-9)

Wet hand, apply to hands, scrub thoroughly, Rinse.

Dosage and Administration (34068-7)

Wet hand, apply palmful to hands, scrub thoroughly, Rinse.

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 51727-6 (51727-6)

Inactive Ingredients

camphor, carbomer, ethyl alcohol, fd&c blue no.1, isopropyl alcohol, methylchloroisothiazolinone, methylisothiazolinone, sodium hydroxide, water, cocamide MEA, PEG-18 glycaryl

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Uses

for handwashing to decrease bacteria on the skin.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)