Dermogen (zinc Oxide Cream)

Drug Facts

Composition & Product

Active Ingredients

Zinc Cation (15.25 g)

Inactive Ingredients

Butylated Hydroxytoluene Diazolidinyl Urea Methylparaben Mineral Oil Propylene Glycol Propylparaben Vitamin A Vitamin D .alpha.-tocopherol Petrolatum

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2016-04-04

Medication Information

Purpose

Skin protectant

Description

Zinc Oxide 15.25%

Uses

• helps treat and prevent diaper rash

• protects chafed skin due to diaper rash and helps seal out wetness

Section 42229-5

For the Treatment & Prevention of Diaper Rash

Contains the same active ingredient as Dermocrem^®

Manufactured in the USA for Kramer Novis,

San Juan, PR 00917. T: (787) 767-2072.

www.kramernovis.com

Dermocrem^® is a registered trademark of Forest Tosara Ltd. This product is not manufactured, distributed or marketed by Forest Tosara Ltd.

Section 50565-1

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

Warning

• For external use only.

When using this product • do not get into eyes

Stop and ask a doctor if • condition worsens • symptoms lasts more than 7 days or clear up and occur again within a few days

Packaging

Directions

• change wet or soiled diapers promptly. • cleanse the diaper area • allow to dry • apply cream liberally as often as necessary, with each diaper, especially at bedtime or anytime when exposure to wet diapers may be prolonged

Drug Facts

Active Ingredient

Zinc Oxide 15.25%

Other Information

• Store at controlled room temperature 15°-30°C (59°-86°F) • Do not use if seal is broken

Inactive Ingredients

Butylhydroxytoluene, diazolidinyl urea, fragrance, methylparaben, mineral oil, propylene glycol, propylparaben, Vitamin A, Vitamin D, Vitamin E and white petrolatum.

Structured Label Content

Uses

• helps treat and prevent diaper rash

• protects chafed skin due to diaper rash and helps seal out wetness

Section 42229-5 (42229-5)

For the Treatment & Prevention of Diaper Rash

Contains the same active ingredient as Dermocrem^®

Manufactured in the USA for Kramer Novis,

San Juan, PR 00917. T: (787) 767-2072.

www.kramernovis.com

Dermocrem^® is a registered trademark of Forest Tosara Ltd. This product is not manufactured, distributed or marketed by Forest Tosara Ltd.

Section 50565-1 (50565-1)

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

Purpose

Skin protectant

Warning

• For external use only.

When using this product • do not get into eyes

Stop and ask a doctor if • condition worsens • symptoms lasts more than 7 days or clear up and occur again within a few days

Packaging

Directions

• change wet or soiled diapers promptly. • cleanse the diaper area • allow to dry • apply cream liberally as often as necessary, with each diaper, especially at bedtime or anytime when exposure to wet diapers may be prolonged

Drug Facts

Active Ingredient (Active ingredient)

Zinc Oxide 15.25%

Other Information (Other information)

• Store at controlled room temperature 15°-30°C (59°-86°F) • Do not use if seal is broken

Inactive Ingredients (Inactive ingredients)

Butylhydroxytoluene, diazolidinyl urea, fragrance, methylparaben, mineral oil, propylene glycol, propylparaben, Vitamin A, Vitamin D, Vitamin E and white petrolatum.

Advanced Ingredient Data

[{"name": "ZINC CATION", "unii": "13S1S8SF37", "classCode": "ACTIM", "strengthNumerator": "15.25", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "BUTYLATED HYDROXYTOLUENE", "unii": "1P9D0Z171K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIAZOLIDINYL UREA", "unii": "H5RIZ3MPW4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "METHYLPARABEN", "unii": "A2I8C7HI9T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MINERAL OIL", "unii": "T5L8T28FGP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLPARABEN", "unii": "Z8IX2SC1OH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "VITAMIN A", "unii": "81G40H8B0T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "VITAMIN D", "unii": "9VU1KI44GP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": ".ALPHA.-TOCOPHEROL", "unii": "H4N855PNZ1", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PETROLATUM", "unii": "4T6H12BN9U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": " • helps treat and prevent diaper rash • protects chafed skin due to diaper rash and helps seal out wetness", "42229-5": "For the Treatment & Prevention of Diaper Rash Contains the same active ingredient as Dermocrem ® Manufactured in the USA for Kramer Novis, San Juan, PR 00917. T: (787) 767-2072. www.kramernovis.com Dermocrem ® is a registered trademark of Forest Tosara Ltd. This product is not manufactured, distributed or marketed by Forest Tosara Ltd.", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "Purpose": "Skin protectant", "Warning": "• For external use only. When using this product • do not get into eyes Stop and ask a doctor if • condition worsens • symptoms lasts more than 7 days or clear up and occur again within a few days", "Directions": "• change wet or soiled diapers promptly. • cleanse the diaper area • allow to dry • apply cream liberally as often as necessary, with each diaper, especially at bedtime or anytime when exposure to wet diapers may be prolonged", "Active ingredient": "Zinc Oxide 15.25%", "Other information": "• Store at controlled room temperature 15°-30°C (59°-86°F) • Do not use if seal is broken", "Inactive ingredients": "Butylhydroxytoluene, diazolidinyl urea, fragrance, methylparaben, mineral oil, propylene glycol, propylparaben, Vitamin A, Vitamin D, Vitamin E and white petrolatum."}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information