Softlips Vanilla Stick
FDA Label NDC 10742-8508

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 Softlips Vanilla (NDC 10742-8508). 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, 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

Dimethicone 2%

Purpose

Dimethicone - Skin protectant

Uses

helps protect and relieve chapped lips

Warnings

For external use only

Stop Use And Ask A Doctor If

  • 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 as needed

Inactive Ingredients

ozokerite, petrolatum, ethylhexyl palmitate, octyldodecanol, squalane, myristyl myristate, ricinus communis (castor) seed oil, myristyl lactate, cetyl alcohol, myristyl laurate, myristyl alcohol, BHT, flavor, menthol, tocopheryl acetatate [vitamin E]

Questions?

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