Lip Remedy Medicinal Lip Balm
FDA Label NDC 75862-014

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Ganz U.s.a., Llc for the product Lip Remedy Medicinal Lip Balm (NDC 75862-014). 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 ingredients, purposes, uses, warnings, directions, storage and handling, other, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredients

→ Purposes

→ Uses

→ Warnings

→ Directions

→ Storage And Handling

→ Other

→ Inactive Ingredients

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Active Ingredients

Petrolatum 32.3%

Purposes

Skin Protectant

Uses

temporarily protects and helps relieve chapped, cracked lips
temporarily protects lips from drying effects of wind and cold weather

Warnings

For external use only

Directions

Apply as needed.

Storage And Handling

store at 20-25°C (68-77°F)

Other

this is a personal care item and should be used by one individual
You may report a serious adverse reaction to this product to: GANZ U.S.A., LLC, #043, 60 Industrial Parkway, Cheektowaga, New York, 14227-9903

Inactive Ingredients

isopropyl lanolate, lanolin, ozokerite wax, euphorbia cerifera (candelilla) wax, isopropyl myristate, polybutene, diisopropyl adipate, myristyl myristate, flavor, theobroma cacao (cocoa) seed butter, camphor, menthol, phenol, yellow 10 lake, red 6 lake, saccharin, menthoxypropanediol