Skin Protectant

Skin Protectant
SPL v1
SPL
SPL Set ID 448b70db-ca81-db7b-e063-6294a90a5f0d
Route
TOPICAL
Published
Effective Date 2026-01-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lanolin (155 mg) Petrolatum (534 mg)
Inactive Ingredients
Microcrystalline Wax Paraffin Light Mineral Oil Carrot Seed Oil Cod Liver Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-02

Description

Lanolin 15.5% Petrolatum 53.4%

Purpose

Lanolin - Skin protectant Petrolatum - Skin protectant


Medication Information

Purpose

Lanolin - Skin protectant

Petrolatum - Skin protectant

Description

Lanolin 15.5% Petrolatum 53.4%

Uses
  • Helps treat and prevent diaper rash
  • Temporarily protects minor cuts, scrapes, and burns
  • Relieves chapped, chafed, or cracked skin and lips
  • Protects from drying effects of wind and cold weather
Storage
  • Do not exceed 30°C (86°F)
Warnings

For external use only

Directions
  • Skin protectant use: apply as needed
  • Diaper rash use:
  • Change wet and soiled diapers promptly
  • Cleanse the diaper area, and allow to dry
  • Apply ointment liberally with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged
Do Not Use On
  • deep or puncture wounds
  • animal bites
  • serious burns
Tamper Evident
  • Do not use if seal on tube is punctured or missing.
Inactive Ingredients

Carrot seed oil

Cod liver oil(contains vitamin A & D)

Light mineral oil

Microcrystalline wax

Paraffin wax

Principal Display Panel

When Using This Product
  • avoid contact with the eyes.
Stop Use and Ask A Doctor If
  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days.
Keep Out of Reach of Children
  • If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.
Drug Facts: Active Ingredients

Lanolin 15.5%

Petrolatum 53.4%


Structured Label Content

Uses
  • Helps treat and prevent diaper rash
  • Temporarily protects minor cuts, scrapes, and burns
  • Relieves chapped, chafed, or cracked skin and lips
  • Protects from drying effects of wind and cold weather
Purpose

Lanolin - Skin protectant

Petrolatum - Skin protectant

Storage
  • Do not exceed 30°C (86°F)
Warnings

For external use only

Directions
  • Skin protectant use: apply as needed
  • Diaper rash use:
  • Change wet and soiled diapers promptly
  • Cleanse the diaper area, and allow to dry
  • Apply ointment liberally with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged
Do Not Use On (Do not use on)
  • deep or puncture wounds
  • animal bites
  • serious burns
Tamper Evident
  • Do not use if seal on tube is punctured or missing.
Inactive Ingredients

Carrot seed oil

Cod liver oil(contains vitamin A & D)

Light mineral oil

Microcrystalline wax

Paraffin wax

Principal Display Panel

When Using This Product (When using this product)
  • avoid contact with the eyes.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days.
Keep Out of Reach of Children (Keep out of reach of children)
  • If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.
Drug Facts: Active Ingredients

Lanolin 15.5%

Petrolatum 53.4%


Advanced Ingredient Data


Raw Label Data

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