RepHresh Spray

Manufacturer
Fleet Laboratories LTD | Church & Dwight Co., Inc.
Effective date
2018-06-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:55:54

Label at a glance#

ProductRephresh Cooling
Active ingredientHYDROCORTISONE
Label structure15 sections

Dosage and administration

Adults and children under 12 years of age and older: Apply to affected area not more than 3 to 4 times daily Children under 12 years of age: Do not use, consult a doctor When practical, cleanse and dry the affected area before application of this product Remove safety seal and cap

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone 0.5%

OTC - PURPOSE SECTION

External Analgesic/Anti-Itch

USE

INDICATIONS & USAGE SECTION

For the temporary relief of external feminine itching

Other uses of this product should be only under the advice and supervision of a doctor

WARNINGS SECTION

Warning(s) For external vaginal use only

OTC - ASK DOCTOR/PHARMACIST SECTION

Consult a doctor if you are allergic to any ingredient in this product

OTC - WHEN USING SECTION

Avoid contact with eyes

OTC - DO NOT USE SECTION

Do not use if you have vaginal discharge

Do not use more than directed unless told to do so by a doctor

OTC - STOP USE SECTION

Stop use and ask a doctor if condition worsens, symptoms persists for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have consulted a doctor

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 right away

Directions

INSTRUCTIONS FOR USE SECTION

Adults and children under 12 years of age and older: Apply to affected area not more than 3 to 4 times daily

Children under 12 years of age: Do not use, consult a doctor

When practical, cleanse and dry the affected area before application of this product

Remove safety seal and cap

DOSAGE & ADMINISTRATION SECTION

Pump 3-5 times before first use for proper dispensing

Shake gently before applying

Holding tube 6 inches away from vaginal are and apply using 1 quick, firm spray.

Note: Tube is designed to spray upside down, if needed

OTHER SAFETY INFORMATION

Keep away from hear or direct sunlight, store at room temperature

Do not use if safety seal is broken or missing

INACTIVE INGREDIENT SECTION

Water, Propanediol, Propylene Glycol, Pentylene Glycol, Laureth-9, Polysorbate 20, Chamomilla Recutita (Matricaria) Flower Extract, Menthyl Ethylamido Oxalate, Citronellyl Methylcrotonate, Aloe Barbadensis (Aloe Vera) Leaf Juice Powder, Lactic Acid

OTC - QUESTIONS SECTION

Questions? Call us at 800 833 9532 Monday through Friday 9 to 5 pm ET or visit our website at www rephresh com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RepHresh™ Vaginal Anti-Itch Spray

Cooling Relief Spray

#1 Trusted Brand

Gynecologist Recommended

Unscented

0.50 FL OZ (15mL)

0.5% Hydrocortisone

RepHresh Spray.jpgRepHresh Spray.jpg

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
HYDROCORTISONE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2Product name120250325
2d2ef081-4f0c-4669-81e8-32b263669a0aProduct name120230801
4d56e8eb-d741-d4a5-de3f-2bab1af75a60Product name720220608
626d7260-31b5-4412-84fd-579746adb6b3Product name120210513
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
8a011600-5e61-4c59-ab7b-54ab658a3b71Product name220181127
a919621a-248d-3c7a-1084-9f9ce286fdfdProduct name220181009
e7d5a174-836b-a0af-b014-cb0826c69ddcProduct name220181004
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
fcce390d-6460-4701-87cf-940d8800a1c3Product name220180212
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1Product name220150218
02657a3f-1489-66ea-f740-5ab9524e57d7Product name120140508
26f3d783-2cc1-4327-e77d-71804cf675a2Product name120140508
36fdc54c-bbeb-981e-8a53-4d768e283892Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
61e59a42-186b-9f4b-aec3-fb49a6debc31Product name120140508
705740e1-dee5-2610-c5a3-4c59cd9d62afProduct name120140508
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508
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af534dc0-c9e5-19a6-693c-e7ad53714660Product name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70233-774-152020-01-31C16284748780-19d75b9d0-aac5-f424-e053-dadaa90a57ceRepHresh Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70233-774-15Rephresh Cooling1 in 1 CARTONSPRAY11
70233-774-15Rephresh Cooling15 g in 1 BOTTLE, SPRAYSPRAY151

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70233-774REPHRESH COOLING (HYDROCORTISONE) SPRAY [FLEET LABORATORIES LTD]1Legacy NDC, 2 package rows20180613_6e773a02-daf5-4adc-e053-2a91aa0ac054.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70233-77470233-774-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

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
6e773a02-daf6-4adc-e053-2a91aa0ac0546e773a02-daf5-4adc-e053-2a91aa0ac0542018-06-12WarningsExact identifier
spl id: 6e773a02-daf6-4adc-e053-2a91aa0ac054
spl set id: 6e773a02-daf5-4adc-e053-2a91aa0ac054

Reported adverse events (FAERS/openFDA)#

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