FDA.reportPublic FDA data

CVS Maximum Strength Feminine Anti-Itch Cream

Manufacturer
PureTek Corporation
Effective date
2023-01-11
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:40:45

Label at a glance#

ProductCVS Maximum Strength Feminine Anti-Itch Cream
Active ingredientHYDROCORTISONE
Label structure8 sections

Indications and uses

temporarily relieves external feminine itching 

Dosage and administration

Adults and children 12 years and older apply to external vaginal area not more than 3 to 4 times a day Children under 12 years consult a doctor 

Storage and handling

store at 20°-25°F (68°-77°F)

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient
Hydrocortisone 1%

Purposes

OTC - PURPOSE SECTION

Anti-Itch

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves external feminine itching 

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 

OTC - DO NOT USE SECTION

Do not use if you have a vaginal discharge. Consult a physician.

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

Adults and children 12 years and older

  • apply to external vaginal area not more than 3 to 4 times a day

Children under 12 years

  • consult a doctor 

Other information

STORAGE AND HANDLING SECTION

  • store at 20°-25°F (68°-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis (Aloe Vera) Leaf Juice, Aqua (Purified Water), Avena Sativa (Oat) Kernel Extract, Bisabolol, Butyrospermum Parkii (Shea) Butter, Calcium Pantothenate (Vitamin B 5), Carthamus Tinctorius (Safflower) Oleosomes, Cetyl Alcohol, Citric Acid, Dimethicone, Glycerin, Glyceryl Stearate, Maltodextrin, Niacinamide (Vitamin B 3), PEG-100 Stearate, Phenoxyethanol, Pyridoxine HCl (Vitamin B 6), Retinyl Palmitate (Vitamin A), Silica, Sodium Ascorbyl Phosphate (Vitamin C), Sodium Hyaluronate, Sodium Starch Octenylsuccinate, Stearyl Alcohol, Tetrasodium EDTA, Tocopheryl Acetate (Vitamin E), Zingiber Officinale (Ginger) Root Extract.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59088-26859088-268-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
OATZ6J799EAJKIACT
LEVOMENOL24WE03BX2TIACT
SHEA BUTTERK49155WL9YIACT
CALCIUM PANTOTHENATE568ET80C3DIACT
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES9S60Q72309IACT
CETYL ALCOHOL936JST6JCNIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
DIMETHICONE92RU3N3Y1OIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
MALTODEXTRIN7CVR7L4A2DIACT
NIACINAMIDE25X51I8RD4IACT
PEG-100 STEARATEYD01N1999RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PYRIDOXINE HYDROCHLORIDE68Y4CF58BVIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM ASCORBYL PHOSPHATE836SJG51DRIACT
HYALURONATE SODIUMYSE9PPT4THIACT
STEARYL ALCOHOL2KR89I4H1YIACT
EDETATE SODIUMMP1J8420LUIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
GINGERC5529G5JPQIACT
HYDROCORTISONEWI4X0X7BPJACTIB

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
2a95bc22-d194-50e9-e063-6294a90a2fa8330df65d-b72b-46d3-854b-357af1e95a962024-12-31WarningsExact identifier
spl set id: 330df65d-b72b-46d3-854b-357af1e95a96

Reported adverse events (FAERS/openFDA)#

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