Earthmed Lip Balm unflavored .045 g/4.455g

Allantoin · SALVE · Earthmed LLC

No Recall History

Plain English

Earthmed Lip Balm unflavored is a salve containing allantoin at .045 g/4.455g, taken topical. Manufactured by Earthmed LLC.

Key Facts

Brand Name: Earthmed Lip Balm unflavored
Generic Name: Allantoin
NDC Code (Product): 82876-989
Manufacturer: Earthmed LLC
Strength: .045 g/4.455g
Dosage Form: SALVE
Route: TOPICAL
Marketing Status
Application #: M016
Marketing Start: 08/05/2025

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

condition aggravated122 reports

general physical health deterioration121 reports

sepsis121 reports

hyponatraemia120 reports

multiple organ dysfunction syndrome120 reports

off label use118 reports

somnolence118 reports

stress117 reports

abdominal distension108 reports

vomiting107 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses helps prevent and temporarily protects and helps relieve chafed, chapped, or cracked skin • helps prevent and protect from the drying effects of wind and cold weather

Dosage & Administration

Directions • Adults and children 2 years of age and older: Apply as needed • Children under 2 years of age: Do not use, consult a doctor Keep out of reach of children keep out of reach of children Keep out of reach of children keep out of reach of children

Warnings

Warnings FOR EXTERNAL USE ONLY.

Frequently Asked Questions

What is Earthmed Lip Balm unflavored used for?

Earthmed Lip Balm unflavored contains Allantoin. It is a salve taken topical. Consult your doctor for specific uses.

Is Earthmed Lip Balm unflavored a controlled substance?

Earthmed Lip Balm unflavored is not classified as a controlled substance by the DEA.

What is the generic name for Earthmed Lip Balm unflavored?

The generic name for Earthmed Lip Balm unflavored is Allantoin. There are 12 other brand versions of Allantoin.

What is the NDC code for Earthmed Lip Balm unflavored .045 g/4.455g?

The NDC (National Drug Code) for Earthmed Lip Balm unflavored .045 g/4.455g is 82876-989, listed by Earthmed LLC.

Product NDC

82876-989

Package NDC

82876-989-01

Other Allantoin Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)