Carmex Classic Lip Balm Medicated Free Wintergreen Stick Kit
FDA Label NDC 10210-0047

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Carma Laboratories, Inc. for the product Carmex Classic Lip Balm Medicated Free Wintergreen Stick (NDC 10210-0047). 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, uses, warnings, when using this product:, stop use and ask a doctor if:, keep out of reach of children., directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

Kit (Kit)

Kit (Kit)

Package Labeling:10210-0033-1

Box (Box)

Box (Box)

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