Mentholatum Natural Ice Ointment
FDA Label NDC 10742-8980

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by The Mentholatum Company for the product Mentholatum Natural Ice (NDC 10742-8980). 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, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, 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

Active Ingredients

Avobenzone 3%

Dimethicone 1%

Octinoxate 7.5%

Octisalate 5%

Purpose

Avobenzone - Sunscreen

Dimethicone - Skin protectant

Octinoxate - Sunscreen

Octisalate - Sunscreen

Uses

  • helps prevent sunburn
  • temporarily protects chapped or cracked lips

Warnings

For external use only

Do Not Use

on damaged or broken skin

When Using This Product

keep out of eyes. Rinse with water to remove.

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.

Directions

  • apply liberally 15 minutes before sun exposure
  • use a water resistant sunscreen if swimming or sweating
  • reapply at least every 2 hours
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
  • ▪limit time in the sun, especially from 10 a.m. – 2 p.m.
  • ▪wear long-sleeve shirts, pants, hats, and sunglasses
  • children under 6 months: ask a doctor

    • Other information

    • protect this product from excessive heat and direct sun

Inactive Ingredients

mineral oil, ozokerite, petrolatum, tricaprin, fragrance, aloe barbadensis leaf extract, cocos nucifera (coconut) oil, cholecalciferol, menthol, retinyl palmitate, tocopheryl acetate, zea mays (corn) oil

Questions?

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mentholatum.com

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