SPL v36
SPL
SPL Set ID 62ad33f6-46e6-435f-9a5f-e116c3e218bf
Route
TOPICAL
Published
Effective Date 2022-03-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Petrolatum (0.76 g)
Inactive Ingredients
Lavender Oil Vitamin D Vitamin A Palmitate Lanolin Light Mineral Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2010-03-24

Description

Active Ingredient                               Purpose White Petrolatum USP (76%)            Skin Protectant

Indications and Usage

Indications and Usage A skin protectant for the treatment of diaper rash, minor cuts, scrapes, burns and to help relieve chapped and cracked skin and lips.


Medication Information

Indications and Usage

Indications and Usage

A skin protectant for the treatment of diaper rash, minor cuts, scrapes, burns and to help relieve chapped and cracked skin and lips.

Description

Active Ingredient                               Purpose White Petrolatum USP (76%)            Skin Protectant

Section 51945-4

Section 55106-9

Active Ingredient                               Purpose

White Petrolatum USP (76%)            Skin Protectant

Warnings:

For External Use Only

Do Not Get In Eyes

Do Not Use On:

Do not use on:

  • Deep or puncture wounds
  • animal bites
  • serious burns
Uses: Vitamin A D
  • Helps treat and prevent diaper rash
  • Helps seal out wetness
  • Temporarily protects minor * cuts * scrapes * burns
  • Temporarily helps protect and help relieve chapped and cracked skin and lips
  • Helps prevent and protect from the drying effects of wind 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

Other Information:
  • Store at room temperature 15 deg C to 30 deg C    59 deg F to 86 deg F
  • Avoid excessive heat

Inactive Ingredients

Inactive Ingredients: Lanolin, Lavender Oil, Light Liquid Paraffin, Vitamin A, Vitamin D

Directions for Diaper Rash:
  • Change wet and soiled diapers promptly
  • Cleanse the diaper area and allow to dry
  • Apply as needed

Keep Out of Reach of Children

Keep out of reach of children

  • If swallowed, get medical help or contact a Poison Control Center right away.

Stop Use and Ask A Doctor If:
  • If condition worsens
  • symptoms last more than 7 days or clear up and occur again in a few days


Structured Label Content

Section 51945-4 (51945-4)

Section 55106-9 (55106-9)

Active Ingredient                               Purpose

White Petrolatum USP (76%)            Skin Protectant

Warnings:

For External Use Only

Do Not Get In Eyes

Do Not Use On: (Do not use on:)

Do not use on:

  • Deep or puncture wounds
  • animal bites
  • serious burns
Uses: Vitamin A D (Uses: Vitamin_A_D)
  • Helps treat and prevent diaper rash
  • Helps seal out wetness
  • Temporarily protects minor * cuts * scrapes * burns
  • Temporarily helps protect and help relieve chapped and cracked skin and lips
  • Helps prevent and protect from the drying effects of wind 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

Other Information: (Other information:)
  • Store at room temperature 15 deg C to 30 deg C    59 deg F to 86 deg F
  • Avoid excessive heat

Inactive Ingredients

Inactive Ingredients: Lanolin, Lavender Oil, Light Liquid Paraffin, Vitamin A, Vitamin D

Indications and Usage

Indications and Usage

A skin protectant for the treatment of diaper rash, minor cuts, scrapes, burns and to help relieve chapped and cracked skin and lips.

Directions for Diaper Rash: (Directions for diaper rash:)
  • Change wet and soiled diapers promptly
  • Cleanse the diaper area and allow to dry
  • Apply as needed

Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children

  • If swallowed, get medical help or contact a Poison Control Center right away.

Stop Use and Ask A Doctor If: (Stop use and ask a doctor if:)
  • If condition worsens
  • symptoms last more than 7 days or clear up and occur again in a few days


Advanced Ingredient Data


Raw Label Data

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