Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 5ddb84e9-cdf7-4034-acd2-625f8d6e4601
Route
TOPICAL
Published
Effective Date 2023-10-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hexylresorcinol (0.1 g)
Inactive Ingredients
Yellow Wax Coconut Oil Cottonseed Oil Jojoba Oil Magnesium Oxide Palm Oil Peppermint Oil Sage Oil Silver Stearate Tea Tree Oil Zinc Oxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-10-02

Description

Hexylresorcinol 0.10%                         First Aid Antiseptic

Purpose

Hexylresorcinol 0.10%                         First Aid Antiseptic


Medication Information

Purpose

Hexylresorcinol 0.10%                         First Aid Antiseptic

Description

Hexylresorcinol 0.10%                         First Aid Antiseptic

Uses

First Aid to help protect against infection in minor cuts, scrapes and burns.

Section 50565-1

Section 55105-1

Warnings

For external use only.

Do not usein the eyes or apply over large areas of the body. In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor.

Stop use and ask a doctor if the condition persists or gets worse. Do not uselonger than 1 week unless directed by a doctor. Keep out of reach of children. If swallowed, consult a physician.

Directions

Clean the affected area. Apply a small amount of this product on the area 1 to 3 times daily. May be covered with a sterile bandage.

Product Label

Other Information

Store at room temperature. May temporarily (washable) discolor skin and fabrics in sunlight.

Inactive Ingredients

beeswax, coconut oil (organic), cottonseed oil, jojoba oil, magnesium oxide, MCT oil, peppermint oil, sage oil, silver stearate, tea tree oil, zinc oxide

Active Ingredient                                  purpose

Hexylresorcinol 0.10%                         First Aid Antiseptic


Structured Label Content

Uses

First Aid to help protect against infection in minor cuts, scrapes and burns.

Section 50565-1 (50565-1)

Section 55105-1 (55105-1)

Warnings

For external use only.

Do not usein the eyes or apply over large areas of the body. In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor.

Stop use and ask a doctor if the condition persists or gets worse. Do not uselonger than 1 week unless directed by a doctor. Keep out of reach of children. If swallowed, consult a physician.

Directions

Clean the affected area. Apply a small amount of this product on the area 1 to 3 times daily. May be covered with a sterile bandage.

Product Label (Product label)

Other Information (Other information)

Store at room temperature. May temporarily (washable) discolor skin and fabrics in sunlight.

Inactive Ingredients

beeswax, coconut oil (organic), cottonseed oil, jojoba oil, magnesium oxide, MCT oil, peppermint oil, sage oil, silver stearate, tea tree oil, zinc oxide

Active Ingredient                                  purpose (Active Ingredient                                  Purpose)

Hexylresorcinol 0.10%                         First Aid Antiseptic


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)