FDA.reportPublic FDA data

4sport skincare anti chafing lotion

Manufacturer
4sport D.o.o.
Effective date
2018-06-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:56:09

Label at a glance#

Product4sport skincare anti chafing
Active ingredientLANOLIN
Label structure9 sections

Indications and uses

Temporarily protects the skin and prevents chafing, blisters and irritation.

Label contents#

Full prescribing information#

Active ingredient:

OTC - ACTIVE INGREDIENT SECTION

Lanolin 40%

Purpose

OTC - PURPOSE SECTION

Skin protectant

Uses:

INDICATIONS & USAGE SECTION

Temporarily protects the skin and prevents chafing, blisters and irritation.

Warnings:

WARNINGS SECTION

  • For external use only. Do not use on: deep or puncture wounds, animal bites, serious burns
  • When using this product: use only as directed, avoid contact with eyes or mucous membrane

Stop use and ask a doctor if:

  • Redness occurs, irritation develops, symptoms persist for more than 7 days, or clear up and occur again within a few days
  • If pregnant or breast-feeding ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Direction:

DOSAGE & ADMINISTRATION SECTION

Apply to intact skin before any chafing and blister causing activity. Wash off with mild soap.

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Prunus Dulcis (Sweet Almond) Oil, Mineral Oil, Vitis Vinifera (Grape) Seed Oil, Prunus Armeniaca (Apricot) Seed Oil, Retinyl Palmitate, Linoleic Acid, Parfum/Fragrance, Lavandula Angustifolia (Lavender) Essential oil, Limonene, Linalool

SPL UNCLASSIFIED SECTION

protects and nurtures your skin

The very best from nature

Made with the best ingredients to protect your skin from chafing, blisters and irritation.

No chafing

No blisters

No irritation

No pertroleum

No parabens

No alcohol

Manufactured in EU for:

4SPORT Ltd.,

Ulica Mirka Vadnova 19,

4000 Kranj,Slovenia

www.4sport-skincare.com

Our anti chafing lotion forms a breathable moisture barrier on the skin, to help fight friction. The formulation makes it easy to apply for all-day protection from skin on skin rubbing, chafing from clothing, friction from shoes, protective gear, and other irritants.

  • Sweat and water resistant
  • Whole body use
  • Non-irritating
  • Airless ecosolution pump bottle container

Better safe than sorry!

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1873968lanolin 40 % Topical LotionPSN1
1873968lanolin 400 MG/ML Topical LotionSCD1
1873968lanolin 40 % Topical LotionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71289-101-022021-01-29C16284748780-1ba0f9c33-2d48-a910-e053-dadaa90a0b854sport skincare anti chafing lotion

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71289-101-024sport skincare anti chafing1 in 1 BOXLOTION11
71289-101-024sport skincare anti chafing100 mL in 1 BOTTLE, DISPENSINGLOTION1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71289-1014SPORT SKINCARE ANTI CHAFING (LANOLIN) LOTION [4SPORT D.O.O.]1Legacy NDC, 2 package rows20180703_92af8b60-b612-4484-9830-e399bee6e6c4.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71289-10171289-101-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
LANOLIN7EV65EAW6HACTIB
ALMOND OIL66YXD4DKO9IACT
MINERAL OILT5L8T28FGPIACT
GRAPE SEED OIL930MLC8XGGIACT
APRICOT KERNEL OIL54JB35T06AIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
LINOLEIC ACID9KJL21T0QJIACT
LAVENDER OILZBP1YXW0H8IACT
LIMONENE, (+)-GFD7C86Q1WIACT
LINALOOL, (+/-)-D81QY6I88EIACT

Source Document#

Source XML · Source PDF

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
9f1e9e02-0df7-4a05-8140-892c6ec00a0292af8b60-b612-4484-9830-e399bee6e6c42018-06-25WarningsExact identifier
spl id: 9f1e9e02-0df7-4a05-8140-892c6ec00a02
spl set id: 92af8b60-b612-4484-9830-e399bee6e6c4

Reported adverse events (FAERS/openFDA)#

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