FDA.reportPublic FDA data

Softlips Peppermint Swirl

Manufacturer
The Mentholatum Company
Effective date
2026-03-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:51:11

Label at a glance#

ProductSoftlips Peppermint Swirl
Active ingredientDIMETHICONE
Label structure9 sections

Indications and uses

temporarily protects and helps relieve chapped or cracked lips helps protect from the drying effects of wind and cold weather

Dosage and administration

apply as needed

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 2%

Purpose

OTC - PURPOSE SECTION

Dimethicone - Skin Protectant

Uses

INDICATIONS & USAGE SECTION

  • temporarily protects and helps relieve chapped or cracked lips
  • helps protect from the drying effects of wind and cold weather

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

  • apply as needed

Inactive ingredients

INACTIVE INGREDIENT SECTION

ozokerite, petrolatum, ethylhexyl palmitate, squalane, octyldodecanol, myristyl myristate, ricinus communis (castor) seed oil, myristyl lactate, flavor, cetyl alcohol, myristyl laurate, myristyl alcohol, ammonium glycyrrhizate, BHT, menthol, tocopheryl acetate [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 Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130310742010336GTIN-13: 0310742010336
EAN-13: 0310742010336
GTIN-12: 310742010336
UPC-A: 310742010336
GTIN storage (14 digits): 00310742010336		EB812001 - Peppermint Swirl_Image 2.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10742-8518-2Softlips Peppermint Swirl2 in 1 BLISTER PACKSTICK21
10742-8518-2Softlips Peppermint Swirl2 g in 1 TUBESTICK21

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10742-851810742-8518-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
ETHYLHEXYL PALMITATE2865993309IACT
CETYL ALCOHOL936JST6JCNIACT
SQUALANEGW89575KF9IACT
AMMONIUM GLYCYRRHIZATE3VRD35U26CIACT
PETROLATUM4T6H12BN9UIACT
MYRISTYL LACTATE1D822OC34XIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
CERESINQ1LS2UJO3AIACT
RICINUS COMMUNIS (CASTOR) SEED OILD5340Y2I9GIACT
MYRISTYL LAURATE58U0NZN2BTIACT
OCTYLDODECANOL461N1O614YIACT
MYRISTYL MYRISTATE4042ZC00DYIACT
DIMETHICONE92RU3N3Y1OACTIB
MYRISTYL ALCOHOLV42034O9PUIACT
MENTHOLL7T10EIP3AIACT

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 Peppermint SwirlDIMETHICONEThe Mentholatum Company4dbea50e-d82d-c702-e063-6394a90ac6e42026-03-24WarningsExact identifier
ndc (package): 10742-8518-2
ndc (product): 10742-8518
ndc11 (package): 10742851802
spl id: 4dbea50e-d82e-c702-e063-6394a90ac6e4
spl set id: 4dbea50e-d82d-c702-e063-6394a90ac6e4

Reported adverse events (FAERS/openFDA)#

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