Active Ingredient
Lanolin USP 50%
Lanolin 50% Cream
FDA Label NDC 87236-019
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Aldermed Inc. for the product Lanolin 50% (NDC 87236-019). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, do not use on, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Skin Protectant
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
Warnings
For external use only
Do Not Use On
- deep or puncture wounds
- animal bites
- serious burns
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
If Pregnant Or Breast-Feeding
ask a health professional before use.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Directions
apply as needed
Other Information
- to open: unscrew cap, pull tab to remove foil seal
- store at 15° to 30°C (59° to 86°F)
- avoid excessive heat
- see tube crimp for lot number and expiration date
Inactive Ingredients
cetosteryl alcohol, edetate disodium, fragrance, lanolin alcohols, polysorbate 60, purified water, sodium borate, white petrolatum, white wax
Questions
Call 1-833-605-84-74 9am-5 pm EST M-F
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