Storage and handling
Other information •store at room temperature 68° - 77° F (20° - 25° C)
Other information •store at room temperature 68° - 77° F (20° - 25° C)
Active ingredients
Hydrocortisone 1%
Purpose
Anti-itch
Uses
•temporarily relieves itching associated with minor skin
irritations, inflammation and rashes due to:
•eczema •psoriasis •poison ivy, oak, sumac
•insect bites •detergents •jewelry
•cosmetics •soaps •saborrheiic dermatitis
•temproarily relieves external and genital itching
•other uses of this product should be under advice and
supervision of a doctor
Warnings For external use only.
: Do not use
•in the genital area if you have vaginal discharge. Consult a doctor.
•for the treatment of diaper rash. Consult a doctor.
: When using this product
•avoid contact with eyes.
•do not use more than directed unless told to do so by a doctor.
•do not put directly into rectum by using fingers or
any mechanical device or applicator.
Stop use and ask a doctor if
•condition worsens, symptoms persist 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 asked a doctor •rectal bleeding occurs
. If swallowed, get medical Keep out of reach of children
help or contact a Poison Control Center right away.
Directions
•for itching or skin irritation, inflammation and rashes:
•adults and children 2 years of age and older: apply to
affected area not more than 3 to 4 times daily
•children under 2 years of age: ask a doctor
•for external and genital itching, adults:
•when practical, clean the affected area with mild soap
and warm waterand rinse thoroughly
•gently dry by patting or blotting with toilet tissue or soft
cloth before applying
•apply to affected area not more than 3 to 4 times daily
•children under 12 years of age: ask a doctor
Other information
•store at room temperature 68° - 77° F (20° - 25° C)
aloe barbadensis leaf juice, Inactive ingredients
ceteastrearyl alcohol, edetate disodium, glyceryl
monostearate, methylparaben, mineral oil, polysorbate
60, propylene glycol, span 60, water, white petrolatum
1-800-638-3800 Weekdays 0 AM to 4 PM EST Questions?
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 106258 | hydrocortisone 1 % Topical Cream | PSN | 2 |
| 106258 | hydrocortisone 10 MG/ML Topical Cream | SCD | 2 |
| 106258 | hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical Cream | SY | 2 |
| 106258 | hydrocortisone 1 % Topical Cream | SY | 2 |
| 106258 | hydrocortisone 1 GM per 100 GM Topical Cream | SY | 2 |
| Class | Version | Type | Effective |
|---|---|---|---|
| HYDROCORTISONE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69571-009-01 | Family Wellness | 28 g in 1 TUBE | CREAM | 28 | 2 | |
| 69571-009-01 | Family Wellness | 1 in 1 CARTON | CREAM | 1 | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 69571-009 | 69571-009-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ALOE VERA LEAF | ZY81Z83H0X | IACT |
| CETOSTEARYL ALCOHOL | 2DMT128M1S | IACT |
| EDETATE DISODIUM | 7FLD91C86K | IACT |
| GLYCERYL MONOSTEARATE | 230OU9XXE4 | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| MINERAL OIL | T5L8T28FGP | IACT |
| POLYSORBATE 60 | CAL22UVI4M | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| SORBITAN MONOSTEARATE | NVZ4I0H58X | IACT |
| WATER | 059QF0KO0R | IACT |
| PETROLATUM | 4T6H12BN9U | IACT |
| HYDROCORTISONE | WI4X0X7BPJ | ACTIB |
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 |
|---|---|---|---|---|---|---|
| Family Wellness | HYDROCORTISONE 1% | FRONT PHARMACEUTICAL PLC | ea26265d-f24e-458e-8bf0-287b2d49f4f4 | 2023-10-27 | Warnings | 69571-009-01 69571-009 69571000901 08ad6eaa-df8b-8f2e-e063-6394a90a16b0 ea26265d-f24e-458e-8bf0-287b2d49f4f4 |
Adverse event summaries are temporarily unavailable. Other product information remains available.