Drug Facts

Drug Facts
SPL v8
SPL
SPL Set ID 00100102-c245-4b63-a4ff-794cacda6f17
Route
TOPICAL
Published
Effective Date 2011-03-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Petrolatum (589.5 mg) Lanolin (350 mg)
Inactive Ingredients
Alpha-tocopherol Acetate Cetyl Esters Wax Ethyl Methylphenylglycidate Benzyl Cinnamate Salicylic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2008-01-01 Until 2023-10-31

Description

Active Ingredients Petrolatum USP 58.95% Anhydrous Lanolin USP 35%


Medication Information

Warnings and Precautions

Warnings: For external use only.

Discontinue use if signs of irritation appear. If condition worsens consult a doctor.

Do not use over deep, infected, or puncture wounds.

Indications and Usage

Indications: Temporarily relieves minor burns, dry, chapped, fissured and macerated skin and lips, also relieves Psoriais, Eczema, mild sunburn, abrasions and contusions, diaper dermatitis, hemorrhoids, and prickly heat.

Dosage and Administration

Directions: Apply a thin film to clean, dry skin three times daily. May be covered with sterile gauze, if desired.

Description

Active Ingredients Petrolatum USP 58.95% Anhydrous Lanolin USP 35%

Section 50565-1

Keep from children.

Section 51727-6

Other ingredients: Tocopheryl Acetate, Cetyl Esters, Ethyl Methylphenylglycidate, Benzyl Cinnamate, Salicylic Acid.

Section 51945-4

NDC 68605-3700-5

VERADEX-E® OINTMENT

Super Emollient, Protectant

Healing Ointment

Net Wt. 100g.

U.S. Pat. # 5,645,826

ABBE LABORATORIES, INC.TM

Farmingdale, NY 11735

Section 55105-1

Purpose

Petrolatum USP 58.95%  ..................................  Protectant

Anhydrous Lanolin USP 35%  .......................  Protectant

Section 55106-9

Active Ingredients

Petrolatum USP 58.95%

Anhydrous Lanolin USP 35%


Structured Label Content

Indications and Usage (34067-9)

Indications: Temporarily relieves minor burns, dry, chapped, fissured and macerated skin and lips, also relieves Psoriais, Eczema, mild sunburn, abrasions and contusions, diaper dermatitis, hemorrhoids, and prickly heat.

Dosage and Administration (34068-7)

Directions: Apply a thin film to clean, dry skin three times daily. May be covered with sterile gauze, if desired.

Warnings and Precautions (34071-1)

Warnings: For external use only.

Discontinue use if signs of irritation appear. If condition worsens consult a doctor.

Do not use over deep, infected, or puncture wounds.

Section 50565-1 (50565-1)

Keep from children.

Section 51727-6 (51727-6)

Other ingredients: Tocopheryl Acetate, Cetyl Esters, Ethyl Methylphenylglycidate, Benzyl Cinnamate, Salicylic Acid.

Section 51945-4 (51945-4)

NDC 68605-3700-5

VERADEX-E® OINTMENT

Super Emollient, Protectant

Healing Ointment

Net Wt. 100g.

U.S. Pat. # 5,645,826

ABBE LABORATORIES, INC.TM

Farmingdale, NY 11735

Section 55105-1 (55105-1)

Purpose

Petrolatum USP 58.95%  ..................................  Protectant

Anhydrous Lanolin USP 35%  .......................  Protectant

Section 55106-9 (55106-9)

Active Ingredients

Petrolatum USP 58.95%

Anhydrous Lanolin USP 35%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)