Vitamin A And D Ointment

SPL v4

SPL

SPL Set ID 453dffec-de9d-0eac-e054-00144ff8d46c

Route

TOPICAL

Published

Effective Date 2017-01-04

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Petrolatum (53.4 g) Lanolin (15.5 g)

Inactive Ingredients

Microcrystalline Wax Paraffin Cod Liver Oil Mineral Oil

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2017-01-03

Description

Lanolin 15.5% Petrolatum 53.4%

Purpose

Skin Protectant

Medication Information

Purpose

Skin Protectant

Description

Lanolin 15.5% Petrolatum 53.4%

Uses

Helps treat and prevent diaper rash

Protects chafed skin due to diaper rash and helps seal out wetness

Section 42229-5

Distributed by

Trifecta Pharmaceuticals USA

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL. 33301

Product of PRC

www.trifecta-pharma.com

Section 44425-7

Store at controlled room temperature 20º 25ºC (68º-77ºF)

Questions 1-888-296-9067

Warnings

For external use only

When using this product avoid contact with eyes

Packaging

Directions

Change wet and soiled diapers promptly

Cleanse the diaper area and allow to dry

Apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

Active Ingredient

Lanolin 15.5%

Petrolatum 53.4%

Inactive Ingredients

Cod liver oil (contains Vitamin A and Vitamin D), Fragrance, Mineral Oil, Microcrystalline Wax, Paraffin

Stop Use and Ask A Doctor

Condition worsens

Symptoms last more than 7 days or clear up and occur again with a few days

Keep Our of Reach of Children

If swallowed, get medical help or contact a Poison Control Center immediately

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)

Distributed by

Trifecta Pharmaceuticals USA

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL. 33301

Product of PRC

www.trifecta-pharma.com

Section 44425-7 (44425-7)

Store at controlled room temperature 20º 25ºC (68º-77ºF)

Questions 1-888-296-9067

Purpose

Skin Protectant

Warnings

For external use only

When using this product avoid contact with eyes

Packaging

Directions

Change wet and soiled diapers promptly

Cleanse the diaper area and allow to dry

Apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

Active Ingredient

Lanolin 15.5%

Petrolatum 53.4%

Inactive Ingredients

Cod liver oil (contains Vitamin A and Vitamin D), Fragrance, Mineral Oil, Microcrystalline Wax, Paraffin

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

Condition worsens

Symptoms last more than 7 days or clear up and occur again with a few days

Keep Our of Reach of Children (Keep our of reach of children)

If swallowed, get medical help or contact a Poison Control Center immediately

Advanced Ingredient Data

[{"name": "MICROCRYSTALLINE WAX", "unii": "XOF597Q3KY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PARAFFIN", "unii": "I9O0E3H2ZE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PETROLATUM", "unii": "4T6H12BN9U", "classCode": "ACTIB", "strengthNumerator": "53.4", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "COD LIVER OIL", "unii": "BBL281NWFG", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MINERAL OIL", "unii": "T5L8T28FGP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LANOLIN", "unii": "7EV65EAW6H", "classCode": "ACTIB", "strengthNumerator": "15.5", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}]

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": "Distributed by Trifecta Pharmaceuticals USA 101 NE Third Avenue, Suite 1500 Ft. Lauderdale, FL. 33301 Product of PRC www.trifecta-pharma.com", "44425-7": "Store at controlled room temperature 20º 25ºC (68º-77ºF) Questions 1-888-296-9067", "Purpose": "Skin Protectant", "Warnings": "For external use only When using this product avoid contact with eyes", "Directions": "Change wet and soiled diapers promptly Cleanse the diaper area and allow to dry Apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.", "Active Ingredient": "Lanolin 15.5% Petrolatum 53.4%", "Inactive Ingredients": "Cod liver oil (contains Vitamin A and Vitamin D), Fragrance, Mineral Oil, Microcrystalline Wax, Paraffin", "Stop use and ask a doctor": "Condition worsens Symptoms last more than 7 days or clear up and occur again with a few days", "Keep our of reach of children": "If swallowed, get medical help or contact a Poison Control Center immediately"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:57.702045 · Updated: 2026-03-14T23:06:08.994677