Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 9da1bd69-eab6-493b-8f5c-5247f8af237c
Route
TOPICAL
Published
Effective Date 2016-10-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzethonium (1 g) Thymol (2 g)
Inactive Ingredients
Allantoin Fd&c Blue No. 1 Cetostearyl Alcohol Chamomile Glycerin Isohexadecane Lanolin Mineral Oil Petrolatum Polihexanide Polysorbate 80 Shea Butter Sodium Acrylate/sodium Acryloyldimethyltaurate Copolymer (4000000 Mw) Steareth-2 Steareth-21 Water Achillea Millefolium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-10-27

Description

Benzethonium Chloride............Antiseptic Thymol................................Antiseptic

Purpose

Benzethonium Chloride............Antiseptic Thymol................................Antiseptic

Storage and Handling

Store at room temperature, avoid freezing


Medication Information

Warnings and Precautions

Warnings For external use only.

Indications and Usage

Do not use on children under 2 years of age unless directed by a doctor.

When using this product avoid contact with eyes.

Purpose

Benzethonium Chloride............Antiseptic Thymol................................Antiseptic

Storage and Handling

Store at room temperature, avoid freezing

Description

Benzethonium Chloride............Antiseptic Thymol................................Antiseptic

Uses

Helps protect skin and supports healing of minor cuts, scrapes, burns and wounds, including pressure sores, diabetic ulcers, cracked skin and lips. Topical antiseptic to help decrease the risk of skin infections.

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if condition worsens, symptoms last more than 7 days or clear up and occur again within a few days.

60g Plpldp

90g plpldp

120g plpldp

directions:

Adults and children 2 years of age and older:

Clean affected area from dirt and debris, let it dry. Apply a thin layer of ForticeptTM Antimicrobial Gel and cover affected area with a clean bandage if needed. Repeat this procedure 1-3 times daily or as needed until condition improves.

Children under 2 years of age:  please, consult a doctor

inactive Ingredients:

Allantoin, Blue #1 dye, Cetearyl Alcohol, Chamomile (Matricaria recutita) Extract, Glycerin, Lanolin, Mineral oil, Petrolatum, Polyhexanide, Shea Butter, Simulgel EG, Steareth-2, Steareth-21, Water, Yarrow (Achillea millefolium) Extract

storage and Handling:

Store at room temperature, avoid freezing

Active Ingredient/purpose

Benzethonium Chloride............Antiseptic

Thymol................................Antiseptic


Structured Label Content

Uses

Helps protect skin and supports healing of minor cuts, scrapes, burns and wounds, including pressure sores, diabetic ulcers, cracked skin and lips. Topical antiseptic to help decrease the risk of skin infections.

Indications and Usage (34067-9)

Do not use on children under 2 years of age unless directed by a doctor.

When using this product avoid contact with eyes.

Warnings and Precautions (34071-1)

Warnings For external use only.

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 50566-9 (50566-9)

Stop use and ask a doctor if condition worsens, symptoms last more than 7 days or clear up and occur again within a few days.

60g Plpldp (60g PLPLDP)

90g plpldp (90g PLPLDP)

120g plpldp (120g PLPLDP)

directions: (Directions:)

Adults and children 2 years of age and older:

Clean affected area from dirt and debris, let it dry. Apply a thin layer of ForticeptTM Antimicrobial Gel and cover affected area with a clean bandage if needed. Repeat this procedure 1-3 times daily or as needed until condition improves.

Children under 2 years of age:  please, consult a doctor

inactive Ingredients: (Inactive ingredients:)

Allantoin, Blue #1 dye, Cetearyl Alcohol, Chamomile (Matricaria recutita) Extract, Glycerin, Lanolin, Mineral oil, Petrolatum, Polyhexanide, Shea Butter, Simulgel EG, Steareth-2, Steareth-21, Water, Yarrow (Achillea millefolium) Extract

storage and Handling: (Storage and handling:)

Store at room temperature, avoid freezing

Active Ingredient/purpose (Active Ingredient/Purpose)

Benzethonium Chloride............Antiseptic

Thymol................................Antiseptic


Advanced Ingredient Data


Raw Label Data

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