Premier Value Merthiolate

SPL v2

SPL

SPL Set ID 40edb2ca-a6c6-4199-a32d-4b4e6b1d063c

Route

TOPICAL

Published

Effective Date 2017-10-26

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Benzalkonium (1.3 mg)

Inactive Ingredients

Acetone Fd&c Red No. 4 Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2017-10-26

Description

Drug Facts

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Drug Facts

Label

Warnings

For external use only.

Directions

Adults and children 2 years and older. Clean the affected area; apply a small amount on the area 1 to 3 times daily; may be covered with a sterile bandage. If bandaged, let dry first.
Children under 2 yrs. of age: Consult a doctor.

Indications

First aid antiseptic to help skin infection in minor: cuts, scrapes, burns, insect bites.

Active Ingredient

Benzalkonium Chloride 0.13%

Inactive Ingredient

Acetone, FD&C Red No 4. Purified water.

Premier Value Merthiolate

Drug Facts

Stop Use and Ask A Doctor If

Redness, swelling or pain persists or increases.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center immediately. Soap will deactivate the effects of this product.

When Using This Product Do Not

Get into the eyes

Apply over large areas of the body

Apply over raw surfaces or blistered areas

Use longer than one week unless directed by doctor.

Ask A Doctor Before Use If You Have

Deep or puncture wounds

Animal bites

Serious burns

Structured Label Content

Label

Purpose

Antiseptic

Warnings

For external use only.

Directions

Adults and children 2 years and older. Clean the affected area; apply a small amount on the area 1 to 3 times daily; may be covered with a sterile bandage. If bandaged, let dry first.
Children under 2 yrs. of age: Consult a doctor.

Indications

First aid antiseptic to help skin infection in minor: cuts, scrapes, burns, insect bites.

Active Ingredient

Benzalkonium Chloride 0.13%

Inactive Ingredient

Acetone, FD&C Red No 4. Purified water.

Premier Value Merthiolate

Drug Facts

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

Redness, swelling or pain persists or increases.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center immediately. Soap will deactivate the effects of this product.

When Using This Product Do Not (When using this product do not)

Get into the eyes

Apply over large areas of the body

Apply over raw surfaces or blistered areas

Use longer than one week unless directed by doctor.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

Deep or puncture wounds

Animal bites

Serious burns

Advanced Ingredient Data

[{"name": "ACETONE", "unii": "1364PS73AF", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 4", "unii": "X3W0AM1JLX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZALKONIUM", "unii": "7N6JUD5X6Y", "classCode": "ACTIB", "strengthNumerator": "1.3", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Purpose": "Antiseptic", "Warnings": "For external use only.", "Directions": "Adults and children 2 years and older. Clean the affected area; apply a small amount on the area 1 to 3 times daily; may be covered with a sterile bandage. If bandaged, let dry first. Children under 2 yrs. of age: Consult a doctor.", "Indications": "First aid antiseptic to help skin infection in minor: cuts, scrapes, burns, insect bites.", "Active Ingredient": "Benzalkonium Chloride 0.13%", "Inactive Ingredient": "Acetone, FD&C Red No 4. Purified water.", "Premier Value Merthiolate": "Drug Facts", "Stop use and ask a doctor if": "Redness, swelling or pain persists or increases.", "Keep out of reach of children.": "If swallowed, get medical help or contact a Poison Control Center immediately. Soap will deactivate the effects of this product.", "When using this product do not": "Get into the eyes Apply over large areas of the body Apply over raw surfaces or blistered areas Use longer than one week unless directed by doctor.", "Ask a doctor before use if you have": "Deep or puncture wounds Animal bites Serious burns"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:27.314733 · Updated: 2026-03-14T22:54:56.160161