FDA.reportPublic FDA data

SeaCalm Skin TM Itch Relief Instant Cooling Spray

Manufacturer
GUTHY-RENKER, LLC
Effective date
2019-03-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:25:11

Label at a glance#

ProductSeaCalm Skin Itch Relief Instant Cooling
Active ingredientHYDROCORTISONE
Label structure10 sections

Indications and uses

Temporarily relieves itching associated with minor skin irritations, inflammation and rashes due to eczema and psoriasis. Other uses of this product should be only under advice and supervision of a doctor.

Dosage and administration

Adults and children 2 years of age and older: For intensive relief, spray affected areas, using a clean fingertip to evenly distribute for complete coverage. Give spray 30 to 60 seconds to absorb and dry, rubbing in as needed. Use up to 3 times a day for a maximum of 7 consecutive days. If you begin a 7-day cycle, wait 23 days before starting a new cycle. Once spray has dried, apply Daily Restore Moisture-Lock Bod...

Label contents#

Full prescribing information#

Active ingredient Purpose

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone - 1.00% Anti-itch spray

Purpose

OTC - PURPOSE SECTION

Anti-itch spray

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves itching associated with minor skin irritations, inflammation and rashes due to eczema and psoriasis. Other uses of this product should be only under advice and supervision of a doctor.

WARNINGS SECTION

Warnings

For external use only.

Keep out of reach of the children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is 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:

For intensive relief, spray affected areas, using a clean fingertip to evenly distribute for complete coverage. Give spray 30 to 60 seconds to absorb and dry, rubbing in as needed. Use up to 3 times a day for a maximum of 7 consecutive days. If you begin a 7-day cycle, wait 23 days before starting a new cycle. Once spray has dried, apply Daily Restore Moisture-Lock Body Cream on both affected and non-affected areas as needed.

Children under 2 years of age: Do not use.

Consult a doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

WATER, BUTYLENE GLYCOL, 1,2-HEXANEDIOL, PROPANEDIOL, HEPTYL GLUCOSIDE, MENTHOXYPROPANEDIOL, FUCUS VESICULOSUS EXTRACT, AVENA SATIVA (OAT) KERNEL EXTRACT, ZINGIBER OFFICINALE (GINGER) ROOT EXTRACT, CRAMBE MARITIMA LEAF EXTRACT, NIACINAMIDE, BISABOLOL, SODIUM PHYTATE, GLYCERIN, CITRIC ACID, SODIUM CITRATE, BENZYL ALCOHOL, POTASSIUM SORBATE.

When using this product

OTC - WHEN USING SECTION

  • Avoid contact with the eyes
  • Do not exceed the recommended daily dosage unless directed by a doctor
  • Do not use any other hydrocortisone product unless you have consulted a doctor.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • Condition worsens
  • If symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use and consult a doctor.

Principal Display Panel - Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CartonCartonLabelLabel


TEMPORARY RELIEF FROM FLARE-UPS
+ SKIN IRRITATIONS
For unpredictable skin that has no time to waste. Itch Relief Instant Cooling Spray soothes skin quickly as it supports your natural defense system.

  • Ethanol-free spray eliminates drying and stinging effects quickly.
  • Delivers powerful relief while promoting skin health.
  • Specially designed for those prone to eczema and psoriasis.
  • Non greasy feel.


VEGAN
PARABEN + FRAGRANCE FREE
DERMATOLOGIST TESTED
CRUELTY FREE
ALCOHOL (ETHANOL) FREE

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70605-045-662022-05-06C16284748780-1d6a99b39-b8ef-a426-e053-dadaa90af4c2SeaCalm Skin TM Itch Relief Instant Cooling Spray
70605-045-662022-01-28C16284748780-1d6a99b39-b8ef-a426-e053-dadaa90af4c2SeaCalm Skin TM Itch Relief Instant Cooling Spray

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70605-04570605-045-66

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
LEVOMENOL24WE03BX2TIACT
GLYCERINPDC6A3C0OXIACT
CRAMBE MARITIMA LEAFNO0DI2V62BIACT
GINGERC5529G5JPQIACT
WATER059QF0KO0RIACT
SODIUM CITRATE1Q73Q2JULRIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
3-((L-MENTHYL)OXY)PROPANE-1,2-DIOLKD6TZ2QICHIACT
PROPANEDIOL5965N8W85TIACT
HEPTYL GLUCOSIDEBU2OC48XBRIACT
HYDROCORTISONEWI4X0X7BPJACTIB
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
BENZYL ALCOHOLLKG8494WBHIACT
PHYTATE SODIUM88496G1ERLIACT
NIACINAMIDE25X51I8RD4IACT
FUCUS VESICULOSUS535G2ABX9MIACT
OAT KERNEL OIL3UVP41R77RIACT
POTASSIUM SORBATE1VPU26JZZ4IACT

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
b66116ce-dc49-4da1-ba66-a642e5cc25e2866f1c62-a3b4-79d6-e053-2a91aa0a3e7f2022-05-06WarningsExact identifier
spl set id: 866f1c62-a3b4-79d6-e053-2a91aa0a3e7f

Reported adverse events (FAERS/openFDA)#

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