43473-091, Health Beyond Vitamins Ad Ointment

43473-091, Health Beyond Vitamins Ad Ointment
SPL v2
SPL
SPL Set ID de87da51-cf92-402c-b60f-5f28d1724124
Route
TOPICAL
Published
Effective Date 2025-11-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Petrolatum (76 g)
Inactive Ingredients
Mineral Oil Microcrystalline Wax Paraffin Vitamin A Palmitate Vitamin D

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-11-22

Description

Active ingredient White Petroletum USP, 76% w/w


Medication Information

Warnings and Precautions

Warnings

For external use only

When using this product

  • Do not get into eyes
Indications and Usage

Uses

  • Helps treat and prevent diaper rash
  • Helps seal out wetness
  • Temporarily protects minor cuts, scrapes, burns
  • Temporarily helps protect and relieve chapped and cracked skin or lips
  • Helps prevent and protect from the drying effects of winds and cold weather
  • Helps prevent and protect chafed skin or minor skin irritations associated with diaper rash
  • With each diaper change, especially at bedtime when exposure to wet diapers may be prolonged

Dosage and Administration

Directions 

  • Apply as needed
  • For diaper rash: Change wet and soiled diapers promptly. Cleanse the diaper area and allow to dry
Description

Active ingredient White Petroletum USP, 76% w/w

Section 44425-7

Other information

  • Store at 59-86F (15-30C)
  • Avoid excessive heat
Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if

  • Condition worsens
  • Symptoms last more than 7 days or clear up and occur again in a few days
Section 50570-1

Do not use on

  • Deep puncture wounds
  • Animal bites
  • Serious burns
Section 51727-6

Inactive ingredients

Cera Microcrystalline, Mineral Oil, Paraffin, Vitamin A, Vitamin A Palmitate, Vitamin D3

Section 51945-4

Section 55105-1

Purpose

Skin Protectant

Section 55106-9

Active ingredient

White Petroletum USP, 76% w/w


Structured Label Content

Indications and Usage (34067-9)

Uses

  • Helps treat and prevent diaper rash
  • Helps seal out wetness
  • Temporarily protects minor cuts, scrapes, burns
  • Temporarily helps protect and relieve chapped and cracked skin or lips
  • Helps prevent and protect from the drying effects of winds and cold weather
  • Helps prevent and protect chafed skin or minor skin irritations associated with diaper rash
  • With each diaper change, especially at bedtime when exposure to wet diapers may be prolonged

Dosage and Administration (34068-7)

Directions 

  • Apply as needed
  • For diaper rash: Change wet and soiled diapers promptly. Cleanse the diaper area and allow to dry
Warnings and Precautions (34071-1)

Warnings

For external use only

When using this product

  • Do not get into eyes
Section 44425-7 (44425-7)

Other information

  • Store at 59-86F (15-30C)
  • Avoid excessive heat
Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • Condition worsens
  • Symptoms last more than 7 days or clear up and occur again in a few days
Section 50570-1 (50570-1)

Do not use on

  • Deep puncture wounds
  • Animal bites
  • Serious burns
Section 51727-6 (51727-6)

Inactive ingredients

Cera Microcrystalline, Mineral Oil, Paraffin, Vitamin A, Vitamin A Palmitate, Vitamin D3

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Skin Protectant

Section 55106-9 (55106-9)

Active ingredient

White Petroletum USP, 76% w/w


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)