Active Ingredients
Camphor 0.5%
Menthol 1%
Softlips Naturals Medicated Stick
FDA Label NDC 10742-8481
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 Naturals Medicated (NDC 10742-8481). 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, when using this product, stop use and ask a doctor if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
External analgesic
External analgesic
Uses
- temporarily protects and helps relieve chapped or cracked lips
- for the temporarily relief of pain associated with minor skin irritation, chapped or cracked lips
Warnings
For external use only
When Using This Product
- do not get into eyes
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
- adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
- children under 2 years of age: ask a doctor
Other Information
- this is a personal care item and should be used by one individual only
- protect this product from excessive heat and direct sun
Inactive Ingredients
olea europaea (olive) fruit oil, beeswax, cocos nucifera (coconut) oil, squalane, ricinus communis (castor) seed oil, bis-diglyceryl polyacyladipate-2, butyrospermum parkii (shea) butter, simmondsia chinensis (jojoba) seed oil, brassica campestris/aleurites fordi oil copolymer, flavor, helianthus annuus (sunflower) seed oil, argania spinosa [argan] kernel oil, camellia sinensis [green tea] seed oil, glycine soja (soybean) oil, honey [manuka], plukenetia volubilis [sacha inchi] seed oil, rosmarinus officinalis (rosemary) leaf extract, stevia rebaudiana extract, tocopherol [vitamin E]
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