FDA.reportPublic FDA data

SWIMMERS ITCH GUARD

Manufacturer
RESOLUTIONS LLC
Effective date
2022-02-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:16:52

Label at a glance#

ProductSWIMMERS ITCH GUARD
Active ingredientEUCALYPTUS OIL
Label structure8 sections

Indications and uses

PREVENT SWIMMER'S ITCH SAFE FOR CHILDREN LONG LASTING PROTECTION

Dosage and administration

Apply sunscreen first, especially spray-on sunscreens which contain alcohol (alcohol removes our product). Before entering the water, apply Swimmer’s Itch Guard to all uncovered skin that will be under water continuously for 5 minutes or longer. Apply liberally and evenly. When coming out of the water, light toweling off is best because it minimizes removal of Swimmer’s Itch Guard. Reapply after 60 minutes of wate...

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

EUCALYPTUS OIL 20%

PURPOSE

OTC - PURPOSE SECTION

SKIN PROTECTANT

USES

INDICATIONS & USAGE SECTION

  • PREVENT SWIMMER'S ITCH
  • SAFE FOR CHILDREN
  • LONG LASTING PROTECTION

WARNINGS

WARNINGS SECTION

TOPICAL CREAM - FOR EXTERNAL USE ONLY - KEEP OUT OF EYES. FLUSH THOROUGHLY AND GENTLY WITH WARM WATER FOR 10-15 MINUTES. STOP USE AND CONSULT PHYSICIAN IF RASH OR IRRITATION DEVELOPS. CONSULT PHYSICIAN BEFORE USING IF PREGNANT OR NURSING.

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 IMMEDIATELY.

DIRECTIONS (FOR CHILDREN 2 YEARS AND OLDER AND ADULTS):

DOSAGE & ADMINISTRATION SECTION

Apply sunscreen first, especially spray-on sunscreens which contain alcohol (alcohol removes our product). Before entering the water, apply Swimmer’s Itch Guard to all uncovered skin that will be under water continuously for 5 minutes or longer. Apply liberally and evenly. When coming out of the water, light toweling off is best because it minimizes removal of Swimmer’s Itch Guard. Reapply after 60 minutes of water activity, taking a shower or hot-tub, or repeated hard toweling offs. Wash swimsuits separately in warm water.

OTHER INGREDIENTS:

INACTIVE INGREDIENT SECTION

Fractionated Coconut Oil, Olive Oil, Avocado Oil, High Oleic Safflower Oil, Cinnamon Oil, d-alpha Tocopherol (Vitamin E).

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01b LBL_2022 Revised SwimmersItchGuard_Label_2x8.5_2017_0101b LBL_2022 Revised SwimmersItchGuard_Label_2x8.5_2017_01

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63264-102-082024-01-30C16284748780-11030e365-4c4a-111a-e063-dadaa90a10e2RESOLUTIONS - SWIMMER'S ITCH GUARD (63264-102)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63264-102-08SWIMMERS ITCH GUARD237 mL in 1 JAROIL2371

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63264-102SWIMMERS ITCH GUARD (EUCALYPTUS) OIL [RESOLUTIONS LLC]1Legacy NDC, 1 package rows20220219_d84ed5cb-9e0d-977d-e053-2995a90aadc1.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63264-10263264-102-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
EUCALYPTUS OIL2R04ONI662ACTIB
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
OLIVE OIL6UYK2W1W1EIACT
SAFFLOWER OIL65UEH262ISIACT
.ALPHA.-TOCOPHEROL ACETATE, D-A7E6112E4NIACT
AVOCADO OIL6VNO72PFC1IACT
CINNAMON OILE5GY4I6YCZIACT

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
d84ed2d3-219c-7907-e053-2995a90a3764d84ed5cb-9e0d-977d-e053-2995a90aadc12022-02-17WarningsExact identifier
spl id: d84ed2d3-219c-7907-e053-2995a90a3764
spl set id: d84ed5cb-9e0d-977d-e053-2995a90aadc1

Reported adverse events (FAERS/openFDA)#

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