drug facts

drug facts
SPL v2
SPL
SPL Set ID eae72d60-b1fc-4bf1-b6b4-9d447e1a4fd2
Route
topical
Published
Effective Date 2020-10-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
benzalkonium (0.13 g)
Inactive Ingredients
methylchloroisothiazolinone methylisothiazolinone citric acid monohydrate sodium chloride water sodium laureth sulfate cocamidopropyl betaine coco diethanolamide fd&c red no. 40 fd&c blue no. 1 limonene, (+)- d&c red no. 33 glycerin sulisobenzone lauryl glucoside fd&c yellow no. 5 benzyl alcohol edetate disodium anhydrous magnesium citrate propylene glycol linalool, (+/-)- fd&c yellow no. 6 benzyl benzoate benzyl salicylate .alpha.-hexylcinnamaldehyde magnesium nitrate

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2020-10-23

Purpose

Antibacterial

Description

Benzalkonium Chloride 0.13% w/w


Medication Information

Warnings

For external use only

Purpose

Antibacterial

Directions

Pump onto wet hands, vigorously work into a lather and rinse thoroughly.

Other Information

Store in a cool dry place below 104 °F.

Inactive Ingredients

water, cocamidopropyl betaine, sodium laureth sulfate, cocamide DEA, lauryl glucoside, glycerin, fragrance, citric acid, benzophenone-4, propylene glycol, sodium chloride, benzyl alcohol, magnesium nitrate, methyIchloroisothiazolinone, methylisothiazolinone, red 33, blue 1

Description

Benzalkonium Chloride 0.13% w/w

Use

for washing hands to decrease bacteria on skin.

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if irritation and redness develops.

Section 50567-7

When using this product avoid contact with eyes, in case of eye contact, flush with water.

Active Ingredient

Benzalkonium Chloride 0.13% w/w

Principal Display Panel 400 Ml Label

HOBBY®

Antibacterial

Liquid Hand Soap

BERRY MEDLEY

13.5 FL OZ

(400 ml)


Structured Label Content

Warnings

For external use only

Purpose

Antibacterial

Directions

Pump onto wet hands, vigorously work into a lather and rinse thoroughly.

Other Information (Other information)

Store in a cool dry place below 104 °F.

Inactive Ingredients (Inactive ingredients)

water, cocamidopropyl betaine, sodium laureth sulfate, cocamide DEA, lauryl glucoside, glycerin, fragrance, citric acid, benzophenone-4, propylene glycol, sodium chloride, benzyl alcohol, magnesium nitrate, methyIchloroisothiazolinone, methylisothiazolinone, red 33, blue 1

Use

for washing hands to decrease bacteria on skin.

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation and redness develops.

Section 50567-7 (50567-7)

When using this product avoid contact with eyes, in case of eye contact, flush with water.

Active Ingredient (Active ingredient)

Benzalkonium Chloride 0.13% w/w

Principal Display Panel 400 Ml Label (Principal Display Panel - 400 mL Label)

HOBBY®

Antibacterial

Liquid Hand Soap

BERRY MEDLEY

13.5 FL OZ

(400 ml)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)