FDA.reportPublic FDA data

Softlips Naturals Medicated

Manufacturer
The Mentholatum Company
Effective date
2026-03-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:51:50

Label at a glance#

ProductSoftlips Naturals Medicated
Active ingredientCAMPHOR (NATURAL), MENTHOL
Label structure10 sections

Indications and 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

Dosage and administration

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

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Camphor 0.5%

Menthol 1%

Purpose

OTC - PURPOSE SECTION

External analgesic

External analgesic

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • do not get into eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

OTHER SAFETY 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

INACTIVE INGREDIENT SECTION

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]

Questions?

OTC - QUESTIONS SECTION

1-877-636-2677 MON-FRI 9AM to 5PM (EST)

Package Label/Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image 1Image 1

Package Label/Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image 2Image 2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2056456camphor 0.5 % / menthol 1 % Topical OintmentPSN1
2056456camphor 0.005 MG/MG / menthol 0.01 MG/MG Topical OintmentSCD1
2056456camphor 0.5 % / menthol 1 % Topical OintmentSY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130310742016178GTIN-13: 0310742016178
EAN-13: 0310742016178
GTIN-12: 310742016178
UPC-A: 310742016178
GTIN storage (14 digits): 00310742016178		CB104001 - Softlips Naturals Medicated_Image 1.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10742-8481-1Softlips Naturals Medicated4.2 g in 1 TUBESTICK4.21
10742-8481-1Softlips Naturals Medicated2 in 1 BLISTER PACKSTICK21

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10742-848110742-8481-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL3W1JG795YIIACT
STEVIA REBAUDIUNA LEAF6TC6NN0876IACT
PLUKENETIA VOLUBILIS SEED OIL8ED72Z8J1ZIACT
ROSMARINUS OFFICINALIS (ROSEMARY) LEAF OIL8LGU7VM393IACT
CAMPHOR (NATURAL)N20HL7Q941ACTIB
ARGANIA SPINOSA KERNEL OIL4V59G5UW9XIACT
TOCOPHEROLR0ZB2556P8IACT
RICINUS COMMUNIS (CASTOR) SEED OILD5340Y2I9GIACT
BUTYROSPERMUM PARKII (SHEA) BUTTERK49155WL9YIACT
SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL724GKU717MIACT
OLEA EUROPAEA (OLIVE) FRUIT OIL6UYK2W1W1EIACT
SQUALANEGW89575KF9IACT
CAMELLIA SINENSIS SEED OILO5R6DK2M9KIACT
GLYCINE SOJA (SOYBEAN) OIL UNSAPONIFIABLESWZ7DY7GBV6IACT
HONEYY9H1V576FHIACT
MENTHOLL7T10EIP3AACTIB
BRASSICA CAMPESTRIS (RAPESEED) SEED OILN4G8379626IACT
BEESWAX2ZA36H0S2VIACT
COCOS NUCIFERA (COCONUT) OILQ9L0O73W7LIACT
BIS-DIGLYCERYL POLYACYLADIPATE-26L246LAM9TIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Softlips Naturals MedicatedCAMPHOR, MENTHOLThe Mentholatum Company4e05d134-6c7f-1501-e063-6294a90ad27d2026-03-27WarningsExact identifier
ndc (package): 10742-8481-1
ndc (product): 10742-8481
ndc11 (package): 10742848101
spl id: 4e05d134-6c80-1501-e063-6294a90ad27d
spl set id: 4e05d134-6c7f-1501-e063-6294a90ad27d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.