SPL v1
SPL
SPL Set ID 3aabd4ea-107c-a02c-e063-6294a90aee07
Route
TOPICAL
Published
Effective Date 2025-09-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lanolin (50 g)
Inactive Ingredients
Sorbitan Sesquioleate Lanolin Alcohols Petrolatum Phenoxyethanol Ethylhexylglycerin Sodium Borate Mineral Oil Edetate Disodium Water Yellow Wax

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-15
Description

Lanolin 50%

Purpose

Skin Protectant

Medication Information

Purpose

Skin Protectant

Description

Lanolin 50%

Uses

Uses

  • Temporarily protects minor cuts, scrapes, and burns
  • Temporarily protects and helps relieve chafed, chapped or cracked skin
  • Helps protect from the drying effects of wind and cold weather
Section 51945-4

Warnings

Warnings

For external use only

Directions

apply as needed

Do Not Use On

Do not use on

  • deep or puncture wounds
  • animal bites
  • serious burns
Active Ingredient

Lanolin 50%

Inactive Ingredients

Petrolatum, Mineral Oil, Water, Sorbitan Sesquioleate, Beeswax, Disodium EDTA, Lanolin Alcohol, Sodium Borate, Phenoxyethanol, Ethylhexylglycerin

When Using This Product

When using this product do not get into 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. In case of accidental ingestion contact a physician or Poison Control Center right away.

Structured Label Content

Uses

Uses

  • Temporarily protects minor cuts, scrapes, and burns
  • Temporarily protects and helps relieve chafed, chapped or cracked skin
  • Helps protect from the drying effects of wind and cold weather
Section 51945-4 (51945-4)

Purpose

Skin Protectant

Warnings

Warnings

For external use only

Directions

apply as needed

Do Not Use On (Do not use on)

Do not use on

  • deep or puncture wounds
  • animal bites
  • serious burns
Active Ingredient

Lanolin 50%

Inactive Ingredients

Petrolatum, Mineral Oil, Water, Sorbitan Sesquioleate, Beeswax, Disodium EDTA, Lanolin Alcohol, Sodium Borate, Phenoxyethanol, Ethylhexylglycerin

When Using This Product (When using this product)

When using this product do not get into the eyes

Stop Use and Ask A Doctor If (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)

Keep out of reach of children. In case of accidental ingestion contact a physician or Poison Control Center right away.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:00.152825 · Updated: 2026-03-14T23:10:09.220745