Storage and handling
Other information Store at room temperature 20°-25°C (68°-77°F) lot no. & exp. date: see box or see crimp of tube
Other information Store at room temperature 20°-25°C (68°-77°F) lot no. & exp. date: see box or see crimp of tube
Active ingredient Purpose
Hydrocortisone, USP 1%.......................................Anti-Itch
Uses
for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:
Warnings
For external use only
Do not use
When using this product
Stop use and ask a doctor if
Keep out of reach of children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Other information
Inactive ingredients
aloe vera leaf, butylated hydroxytoluene, ceteth-20, cetyl alcohol, methylparaben, mineral oil, propylene glycol, propylparaben, sorbitan monostearate, stearyl alcohol, water
Distributed By:
Family Dollar Services, Inc.
10401 Monroe Rd.
Matthews, NC 28105 USA
Made in Korea
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 106258 | hydrocortisone 1 % Topical Cream | PSN | 3 |
| 106258 | hydrocortisone 10 MG/ML Topical Cream | SCD | 3 |
| 106258 | hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical Cream | SY | 3 |
| 106258 | hydrocortisone 1 % Topical Cream | SY | 3 |
| 106258 | hydrocortisone 1 GM per 100 GM Topical Cream | SY | 3 |
| Class | Version | Type | Effective |
|---|---|---|---|
| HYDROCORTISONE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 55319-074-28 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-e980-a426-e053-dadaa90af4c2 | 15220ca4-b7de-4657-901a-114e260f0cf1 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55319-074-28 | Family Wellness Maximum Strength Hydrocortisone | 28 g in 1 TUBE | CREAM | 28 | 3 | |
| 55319-074-28 | Family Wellness Maximum Strength Hydrocortisone | 1 in 1 CARTON | CREAM | 1 | 3 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| HYDROCORTISONE | ACTIVE INGREDIENT | WI4X0X7BPJ | 2 | |
| HYDROCORTISONE | ACTIVE MOIETY | WI4X0X7BPJ | 2 | |
| ALOE VERA LEAF | INACTIVE INGREDIENT | ZY81Z83H0X | 2 | |
| BUTYLATED HYDROXYTOLUENE | INACTIVE INGREDIENT | 1P9D0Z171K | 2 | |
| CETETH-20 | INACTIVE INGREDIENT | I835H2IHHX | 2 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | 2 | |
| MINERAL OIL | INACTIVE INGREDIENT | T5L8T28FGP | 2 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 2 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | 2 | |
| SORBITAN MONOSTEARATE | INACTIVE INGREDIENT | NVZ4I0H58X | 2 | |
| STEARYL ALCOHOL | INACTIVE INGREDIENT | 2KR89I4H1Y | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 55319-074 | 55319-074-28 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| HYDROCORTISONE | WI4X0X7BPJ | ACTIB |
| ALOE VERA LEAF | ZY81Z83H0X | IACT |
| BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | IACT |
| CETETH-20 | I835H2IHHX | IACT |
| CETYL ALCOHOL | 936JST6JCN | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| MINERAL OIL | T5L8T28FGP | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| SORBITAN MONOSTEARATE | NVZ4I0H58X | IACT |
| STEARYL ALCOHOL | 2KR89I4H1Y | IACT |
| WATER | 059QF0KO0R | IACT |
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION, SUSPENSION / SUBCUTANEOUS | 0.02 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, DELAYED RELEASE / ORAL | 36 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | POWDER, FOR SUSPENSION / ORAL | 8 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / EPIDURAL | 1 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | FILM, EXTENDED RELEASE / TRANSDERMAL | 58.13 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUSPENSION/ DROPS / OPHTHALMIC | 0.05 %w/w | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | CREAM / VAGINAL | 402 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SUSPENSION / ORAL | 64 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | CAPSULE, LIQUID FILLED / ORAL | 0.1 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SHAMPOO / TOPICAL | 8 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUSPENSION / AURICULAR (OTIC) | NA | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | DROPS / NASAL | 14 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | SHAMPOO / TOPICAL | 0.1 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUSPENSION / ORAL | 388 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SYSTEM / TRANSDERMAL | 6.09 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 19 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | GEL / VAGINAL | 8 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SYSTEM / TOPICAL | 4200 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / AURICULAR (OTIC) | 10 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SHAMPOO, SUSPENSION / TOPICAL | 2 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / INTRAVENOUS | 95 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION/ DROPS / OPHTHALMIC | 0.01 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / VAGINAL | 750 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | OINTMENT / DENTAL | NA | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / OPHTHALMIC | 0.05 %w/w | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | LOTION / TOPICAL | 1000 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | LIQUID / ORAL | 162 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / PERIDURAL | 1 mg | ||
| STEARYL ALCOHOL | STEARYL ALCOHOL | 2KR89I4H1Y | CREAM / VAGINAL | 425 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL / TOPICAL | 19.2 %w/w | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SUSPENSION / AURICULAR (OTIC) | 0.5 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | LOTION / TOPICAL | 3392 mg | ||
| STEARYL ALCOHOL | STEARYL ALCOHOL | 2KR89I4H1Y | CAPSULE, EXTENDED RELEASE / ORAL | 72 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | LOTION / TOPICAL | 351 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | EMULSION / OPHTHALMIC | 1.5 %w/v | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | CAPSULE, EXTENDED RELEASE / ORAL | 0.22 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUSPENSION / RECTAL | 1808 mg | ||
| STEARYL ALCOHOL | STEARYL ALCOHOL | 2KR89I4H1Y | CREAM / TOPICAL | 162000 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | EMULSION / TOPICAL | 8 %w/w | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SUSPENSION / OPHTHALMIC | 0.1 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | OINTMENT / OPHTHALMIC | 0.01 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | CONCENTRATE / ORAL | 12 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION / INTRAMUSCULAR | 7459 mg | ||
| STEARYL ALCOHOL | STEARYL ALCOHOL | 2KR89I4H1Y | SUPPOSITORY / VAGINAL | 8.5 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | OINTMENT / TOPICAL | 57 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 0.8 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | GEL / TOPICAL | 2.5 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SUSPENSION/ DROPS / OPHTHALMIC | 0.01 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / INTRADERMAL | 1 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION/ DROPS / OPHTHALMIC | 0.75 %w/v | ||
| STEARYL ALCOHOL | STEARYL ALCOHOL | 2KR89I4H1Y | AEROSOL, FOAM / TOPICAL | 37 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / ORAL | 27120 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | FILM, EXTENDED RELEASE / TRANSDERMAL | 34 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | TABLET, EXTENDED RELEASE / ORAL | 0.12 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | CREAM / VAGINAL | 3 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | JELLY / NASAL | 250 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | DROPS / ORAL | 200 mg/1ml | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / RECTAL | 0.13 %w/v | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | DROPS / AURICULAR (OTIC) | NA |
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 |
|---|---|---|---|---|---|---|
| 0634f2d0-5577-4df8-a282-d08c90e52422 | 15220ca4-b7de-4657-901a-114e260f0cf1 | 2016-09-19 | Warnings | 0634f2d0-5577-4df8-a282-d08c90e52422 15220ca4-b7de-4657-901a-114e260f0cf1 |
Adverse event summaries are temporarily unavailable. Other product information remains available.