1260

1260
SPL v10
SPL
SPL Set ID 94b277dc-6512-4d36-8485-8ea510097428
Route
TOPICAL
Published
Effective Date 2026-02-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lanolin (50 g)
Inactive Ingredients
Lanolin Alcohols White Wax Mineral Oil Sodium Borate Water Edetate Disodium White Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-10-12
Description

Lanolin USP 50%

Purpose

Skin Protectant

Medication Information

Purpose

Skin Protectant

Description

Lanolin USP 50%

Uses
  • Temporarily protects minor • cuts • scrapes • burns
  • Temporarily protects and helps relieve chafed, chapped, or cracked skin and lips
  • Helps prevent and protect from the drying effects of wind and cold weather
Label

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Warnings

For External Use Only

Directions

Apply as needed

Do Not Use On

• Deep or puncture wounds • Animal bites • Serious burns

Active Ingredient

Lanolin USP 50%

Other Information
  • Store at room temperature 15º-30ºC (59º-86ºF)
  • Avoid excessive heat
  • Tamper evident. Do not use if seal is damaged.
Inactive Ingredients

beeswax (White), edetate disodium, emulsifying wax, lanolin alcohol, mineral oil, mint perfume, petrolatum, purified water, sodium borate

When Using This Product

• Do not get into 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 (1-800-222-1222) Center right away.

Structured Label Content

Uses
  • Temporarily protects minor • cuts • scrapes • burns
  • Temporarily protects and helps relieve chafed, chapped, or cracked skin and lips
  • Helps prevent and protect from the drying effects of wind and cold weather
Label

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Skin Protectant

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 USP 50%

Other Information
  • Store at room temperature 15º-30ºC (59º-86ºF)
  • Avoid excessive heat
  • Tamper evident. Do not use if seal is damaged.
Inactive Ingredients

beeswax (White), edetate disodium, emulsifying wax, lanolin alcohol, mineral oil, mint perfume, petrolatum, purified water, sodium borate

When Using This Product (When using this product)

• Do not get into 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 (1-800-222-1222) Center right away.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:09:03.830799 · Updated: 2026-03-14T23:14:00.268297