Lip Remedy Medicinal Lip Balm
FDA Label NDC 55143-013

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Norwood Packaging Ltd. for the product Lip Remedy Medicinal Lip Balm (NDC 55143-013). 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 other, active ingredients, purposes, uses, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

  • 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

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

Otc - When Using

When using this product keep out of eyes.

Otc - Stop Use

Stop use and ask a doctor if

  • irritation or rash occurs
  • symptoms persist for more than 7 days or clear up and occur again within a few days

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Apply as needed.

Storage And Handling

  • store at 20-25°C (68-77°F)

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

Principal Display Panel - 4 G Blue Carton

Net wt. 4 g (0.14 Oz.)

time & again®
LIP REMEDY medicinal lip balm
with Menthol and Cocoa Seed Butter

Soothes, relieves
and helps to protect
dry chapped lips.

Principal Display Panel (4 g Blue Carton)

Principal Display Panel (4 g Blue Carton)

Principal Display Panel - 4 G Green Carton

Net wt. 4 g (0.14 Oz.)

time & again®
LIP REMEDY medicinal lip balm
with Menthol and Cocoa Seed Butter

Soothes, relieves
and helps to protect
dry chapped lips.

Principal Display Panel (4 g Green Carton)

Principal Display Panel (4 g Green Carton)

Principal Display Panel - 4 G Red Carton

Net wt. 4 g (0.14 Oz.)

time & again®
LIP REMEDY medicinal lip balm
with Menthol and Cocoa Seed Butter

Soothes, relieves
and helps to protect
dry chapped lips.

Principal Display Panel (4 g Red Carton)

Principal Display Panel (4 g Red Carton)

* Please review the disclaimer below.