FDA Label for Carmex Classic Lip Balm Medicated

View Indications, Usage & Precautions

Carmex Classic Lip Balm Medicated Product Label

The following document was submitted to the FDA by the labeler of this product Carma Laboratories, Inc.. 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.

Active Ingredients



Octinoxate 7.50%

Oxybenzone 4.00%

Camphor 1.70%

White Petrolatum 45.30%


Uses



• helps protect against sunburn
• higher SPF gives more sunburn protection

  • helps provide relief of symptoms of cold sores and dry lips

Warnings



Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.


When Using This Product:



keep out of eyes. Rinse with water to remove.

keep out of eyes.


Stop Use And Ask A Doctor If:



rash occurs

• condition worsens • symptoms last more than 7 days or clear up and occur again within a few days


Keep Out Of Reach Of Children.



If swallowed, get medical help or contact a Poison Control Center right away.

If swallowed, get medical help or contact a Poison Control Center right away.


Directions



• apply liberally 15 minutes before sun exposure
• reapply: • after 80 minutes of swimming or sweating • immediately after towel drying
• at least every 2 hours
• children under 2 years of age: ask a doctor

• apply to lips not more than 3 to 4 times daily
• children under 2 years of age: ask a doctor


Inactive Ingredients



petrolatum, lanolin, euphorbia cerifera (candelilla) wax, isopropyl palmitate, ozokerite, beeswax, cetyl esters, paraffin, theobroma cacao (cocoa) seed butter, flavor, limnanthes alba (meadowfoam) seed oil, stevia rebaudiana extract

lanolin, beeswax, cetyl esters, paraffinum liquidum, theobroma cacao seed butter, menthol, salicylic acid, phenol, vanillin, flavor


Purpose



External Analgesic

Lip Protectant


Do Not Use On:



• deep puncture wounds • serious burns • animal bites


Package Labeling:10210-0047-1




Package Labeling:10210-0033-1




* Please review the disclaimer below.