SPL v6
SPL
SPL Set ID a2a41914-c98b-4b35-9d12-6fb0041c7e1d
Route
TOPICAL
Published
Effective Date 2014-06-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (10 g)
Inactive Ingredients
Water Ethylhexyl Palmitate Castor Oil Polyglycerin-6 Polyglyceryl-10 Hexaoleate Glycerin Dimethicone Sodium Pyrrolidone Carboxylate Ceramide 3 Ceramide 6 Ii Ceramide 2 Aloe Vera Leaf Hyaluronic Acid Macadamia Oil Corn Oil Canola Oil Matricaria Chamomilla Whole Panthenol .alpha.-tocopherol Acetate Coco-glycerides Myristyl Myristate Sorbitan Monolaurate Sodium Chloride Zinc Sulfate Anhydrous Potassium Sorbate Lonicera Caprifolium Flower Sodium Benzoate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-01-01

Description

ACTIVE INGREDIENTS ZINC OXIDE, 10%


Medication Information

Warnings and Precautions

WARNINGS

FOR EXTERNAL USE ONLY

Indications and Usage

USE

  • HELPS TREAT AND PREVENT DIAPER RASH.
  • PROTECTS CHAPPED SKIN DUE TO DIAPER RASH AND HELPS PROTECT FROM WETNESS.
Dosage and Administration

DIRECTIONS

  • CHANGE WET AND SOILED DIAPER IMMEDIATELY
  • CLEANSE THE DIAPER AREA AND ALLOW SKIN TO DRY.
  • APPLY OINTMENT LIBERALLY AND AS OFTEN AS NECESSARY WITH EACH DIAPER CHANGE, ESPECIALLY WHEN EXPOSED TO WET DIAPERS FOR A PROLONGED PERIOD OF TIME, SUCH AS BEDTIME.
Description

ACTIVE INGREDIENTS ZINC OXIDE, 10%

Section 50565-1

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, SEEK MEDICAL HELP OR CALL POISON CONTROL CENTER IMMEDIATELY.

Section 50566-9

STOP USE AND ASK A DOCTOR IF CONDITION WORSENS OR DOES NOT IMPROVE AFTER 7 DAYS.

Section 50567-7

WHEN USING THIS PRODUCT DO NOT GET INTO EYES.

Section 51727-6

Inactive Ingredients: Water, Ethylhexyl Palmitate, Ricinus Communis (Castor) Seed Oil, Polyglycerin-6 Polyricinoleate, Polyglyceryl-10 Hexaoleate, Glycerin, Dimethicone, Sodium PCA, Ceramide 2, Ceramide 3, Ceramide 6lf, Aloe Barbadensis Leaf Juice, Hyaluronic Acid, Macadamia Ternifolia Seed Oil, Vegetable Oil, Camellia Saliva Seed Oil, Phytostearyl Canola Glycerides, Chamomilla Recutita (Matricaria) Extract, Panthenol (Vitamin B5), Tocopheryl Linoleate, Hydrogenated Coco-Glycerides, Myristyl Myristate, Sorbitan Laurate, Sodium Chloride, Zinc Sulfate, Lonicera Caprifolium (Honeysuckle) Flower Extract, Sodium Benzoate, Potassium Sorbate.

Section 51945-4

Section 55105-1

PURPOSE

SKIN PROTECTANT

Section 55106-9

ACTIVE INGREDIENTS

ZINC OXIDE, 10%


Structured Label Content

Indications and Usage (34067-9)

USE

  • HELPS TREAT AND PREVENT DIAPER RASH.
  • PROTECTS CHAPPED SKIN DUE TO DIAPER RASH AND HELPS PROTECT FROM WETNESS.
Dosage and Administration (34068-7)

DIRECTIONS

  • CHANGE WET AND SOILED DIAPER IMMEDIATELY
  • CLEANSE THE DIAPER AREA AND ALLOW SKIN TO DRY.
  • APPLY OINTMENT LIBERALLY AND AS OFTEN AS NECESSARY WITH EACH DIAPER CHANGE, ESPECIALLY WHEN EXPOSED TO WET DIAPERS FOR A PROLONGED PERIOD OF TIME, SUCH AS BEDTIME.
Warnings and Precautions (34071-1)

WARNINGS

FOR EXTERNAL USE ONLY

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, SEEK MEDICAL HELP OR CALL POISON CONTROL CENTER IMMEDIATELY.

Section 50566-9 (50566-9)

STOP USE AND ASK A DOCTOR IF CONDITION WORSENS OR DOES NOT IMPROVE AFTER 7 DAYS.

Section 50567-7 (50567-7)

WHEN USING THIS PRODUCT DO NOT GET INTO EYES.

Section 51727-6 (51727-6)

Inactive Ingredients: Water, Ethylhexyl Palmitate, Ricinus Communis (Castor) Seed Oil, Polyglycerin-6 Polyricinoleate, Polyglyceryl-10 Hexaoleate, Glycerin, Dimethicone, Sodium PCA, Ceramide 2, Ceramide 3, Ceramide 6lf, Aloe Barbadensis Leaf Juice, Hyaluronic Acid, Macadamia Ternifolia Seed Oil, Vegetable Oil, Camellia Saliva Seed Oil, Phytostearyl Canola Glycerides, Chamomilla Recutita (Matricaria) Extract, Panthenol (Vitamin B5), Tocopheryl Linoleate, Hydrogenated Coco-Glycerides, Myristyl Myristate, Sorbitan Laurate, Sodium Chloride, Zinc Sulfate, Lonicera Caprifolium (Honeysuckle) Flower Extract, Sodium Benzoate, Potassium Sorbate.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

PURPOSE

SKIN PROTECTANT

Section 55106-9 (55106-9)

ACTIVE INGREDIENTS

ZINC OXIDE, 10%


Advanced Ingredient Data


Raw Label Data

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