FDA Label for Lip Remedy Medicinal Lip Balm Red

View Indications, Usage & Precautions

Lip Remedy Medicinal Lip Balm Red Product Label

The following document was submitted to the FDA by the labeler of this product Norwood Packaging Ltd.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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 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 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.


* Please review the disclaimer below.