Indications and uses
for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to: •eczema •insect bites •poison ivy •poison oak •poison ...
for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to: •eczema •insect bites •poison ivy •poison oak •poison ...
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 •do not use, consult a doctor For external anal itching Adults: when practical, clean the affected area with mild soap and warm water, rinse thoroughly, gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product Children under 12 years of a...
Store at room temperature 59°-86°F (15°-30°C). Protect from freezing. Before using any medication, read all label directions. Keep carton, it contains important information.
Hydrocortisone, USP 1%
Anti-itch
for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to: •eczema •insect bites •poison ivy •poison oak •poison ...
For external use only
•avoid contact with the eyes •do not begin the use of any other hydrocortisone product unless directed by a doctor
•for external anal itching: •do not use more than directed unless directed by a doctor
•do not put this product into the rectum by using fingers or any mechanical device or applicator
•symptoms last for more than 7 days •the condition gets worse •symptoms clear up and occur again in a few days •rectal bleeding occurs, consult doctor promptly
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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 •do not use, consult a doctor
For external anal itching
Adults: when practical, clean the affected area with mild soap and warm water, rinse thoroughly, gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
Children under 12 years of age: consult a doctor
Store at room temperature 59°-86°F (15°-30°C). Protect from freezing.
Before using any medication, read all label directions. Keep carton, it contains important information.
cetostearyl alcohol, sodium cetostearyl sulfate, stearic acid, trolamine, decyl oleate, propylene glycol, water, methyl paraben, propyl paraben, EDTA, vitamin E
ghassan@ohiolabpharma.com
EXTRA STRENGHT
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 70648-002-01 | 2020-08-25 | C162847 | 48780-1 | 9d75b9cf-cdca-f424-e053-dadaa90a57ce | 3a9f578f-ded7-0361-e054-00144ff88e88 |
| 70648-002-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-cdca-f424-e053-dadaa90a57ce | 3a9f578f-ded7-0361-e054-00144ff88e88 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 70648-002 | 70648-002-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| TROLAMINE | 9O3K93S3TK | IACT |
| CETEARETH-12 | 7V4MR24V5P | IACT |
| SODIUM CETOSTEARYL SULFATE | 7ZBS06BH4B | IACT |
| HYDROCORTISONE | WI4X0X7BPJ | ACTIB |
| WATER | 059QF0KO0R | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| CETOSTEARYL ALCOHOL | 2DMT128M1S | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| ALPHA-TOCOPHEROL | H4N855PNZ1 | IACT |
| EDETATE DISODIUM | 7FLD91C86K | IACT |
| OCTYLDODECANOL | 461N1O614Y | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
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 |
|---|---|---|---|---|---|---|
| ada493cd-68ff-2605-e053-2a95a90ab911 | 3a9f578f-ded7-0361-e054-00144ff88e88 | 2020-08-24 | Warnings | 3a9f578f-ded7-0361-e054-00144ff88e88 |
Adverse event summaries are temporarily unavailable. Other product information remains available.