OTC - ACTIVE INGREDIENT SECTION
ACTIVE INGREDIENT: HYDROCORTISONE 1%Cream.
Itch relief Cream
- Manufacturer
- Cintas Corporation | ULTRAtab Laboratories, Inc. | Ultra Seal Corporation
- Effective date
- 2021-01-11
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:57:09
Label at a glance#
ProductItch relief Cream
Active ingredientHYDROCORTISONE
Label structure9 sections
Label contents#
Full prescribing information#
OTC - PURPOSE SECTION
Itch Relief Cream
INACTIVE INGREDIENT SECTION
Inactive Ingredients: Benzoic Acid, Chlorphenesin, Citric Acid, Glycerin,Glycerol Monostearate, Methyl Paraben, Mineral Oil,Petrolatum, Phenoxyethanol,Polysorbate 80,Purified Water, Titanium Dioxide,Trisodium Citrate
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children
INDICATIONS & USAGE SECTION
USES: For the temporary relief of itching associated with minor, skin irritations and rashes due to eczema, insect bites, poison ivy/oak/sumac, soaps, detergents,cosmetics and jewelry
DOSAGE & ADMINISTRATION SECTION
DIRECTIONS: Adults and children 2years of age and older: apply to affected area and not more than 3 to4 times daity. Children under 2: do not use, consult a doctor.
WARNINGS SECTION
WARNINGS: For external use only. Avoid contact with eyes. Discontinue use If conditions persist more than 7 days and consult a physician. Do not use on children under 2 years except under the advice and supervision of a physician. Do not use with any other hydrocortisone product unless you have consulted a doctor. Other uses or this product should be only under the advise or supervision of a doctor.
OTHER SAFETY INFORMATION
Store at room temperature (do not freeze).
PACKET NOT FOR INDIVIDUAL SALE
Tamper evident: Do not use if package is torn or cut.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Products#
Every source-derived product name is available through these pages.
- Itch relief Cream
- Hydrocortisone Cream
- HYDROCORTISONE
- ANHYDROUS TRISODIUM CITRATE
- GLYCERIN
- GLYCERYL MONOSTEARATE
- PETROLATUM
- POLYSORBATE 80
- WATER
- TITANIUM DIOXIDE
- CITRIC ACID MONOHYDRATE
- MINERAL OIL
- BENZOIC ACID
- METHYLPARABEN
- CHLORPHENESIN
- PHENOXYETHANOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 42961-370 | 42961-370-09 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| HYDROCORTISONE | WI4X0X7BPJ | ACTIB |
| ANHYDROUS TRISODIUM CITRATE | RS7A450LGA | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| GLYCERYL MONOSTEARATE | 230OU9XXE4 | IACT |
| PETROLATUM | 4T6H12BN9U | IACT |
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
| WATER | 059QF0KO0R | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| CITRIC ACID MONOHYDRATE | 2968PHW8QP | IACT |
| MINERAL OIL | T5L8T28FGP | IACT |
| BENZOIC ACID | 8SKN0B0MIM | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| CHLORPHENESIN | I670DAL4SZ | IACT |
| PHENOXYETHANOL | HIE492ZZ3T | IACT |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 83a3c1a5-ea24-489b-952e-01ab3565143e | 65817c17-5ecb-4f2f-b588-4354329c1942 | 2022-12-29 | Warnings | 65817c17-5ecb-4f2f-b588-4354329c1942 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.