Indications and uses
for the temporary relief of itching associated with minor skin irritations and rashes.
for the temporary relief of itching associated with minor skin irritations and rashes.
Apply a quarter-sized amount to the top of the head and another quarter-sized amount to the sides of wet hair and scalp. Add additional water and cleanser for increased lather. Massage lather into scalp and rinse thoroughly with warm water. Use daily or minimum of 3 times per week. Children under 2 years of age: do not use, consult a doctor. Store at room temperature.
Drug Facts
Hydrocortisone acetate 0.5%
Antipruritic
For external use only.
Avoid contact with the eyes.
If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and do not begin use of any other hydrocortisone product unless you have consulted a doctor.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Apply a quarter-sized amount to the top of the head and another quarter-sized amount to the sides of wet hair and scalp. Add additional water and cleanser for increased lather. Massage lather into scalp and rinse thoroughly with warm water. Use daily or minimum of 3 times per week. Children under 2 years of age: do not use, consult a doctor. Store at room temperature.
Water, Sodium Lauroyl Methyl Isethionate, Acrylates Copolymer, Decyl Glucoside, Sodium Lauroamphoacetate, Sodium Methyl Cocoyl Taurate, Sodium Cocoyl Isethionate, Butylene Glycol, Glycereth-26, Cocamidopropyl Betaine, Fragrance, Glycerin, Glycol Stearate, Phenoxyethanol, Guar Hydroxypropyltrimonium Chloride, Sodium Hydroxide, Allantoin, BHT, Disodium EDTA, Ethylhexylglycerin, Caprylic/Capric Triglyceride, Methylpropanediol, 4-Terpineol, Isomalt, Rhododendron Ferrugineum Leaf Cell Culture Extract, Lecithin, Lactic Acid, Salicylic Acid, Sea Whip Extract, Salix Alba (Willow) Bark Extract, Menthol, Benzyl Alcohol, Isopropyl Palmitate, Polyglyceryl-4 Laurate, Poloxamer 407, Citric Acid
| Class | Version | Type | Effective |
|---|---|---|---|
| HYDROCORTISONE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 71605-000-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-b73d-f424-e053-dadaa90a57ce | HairSanity™ Step 1 |
| 71605-000-04 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-b73d-f424-e053-dadaa90a57ce | HairSanity™ Step 1 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 71605-000-01 | HairSanity Step 1 | 237 mL in 1 TUBE | SHAMPOO | 237 | 1 | |
| 71605-000-04 | HairSanity Step 1 | 89 mL in 1 TUBE | SHAMPOO | 89 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 71605-000 | 71605-000-01, 71605-000-04 |
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| 48e7b70c-97f4-410d-a299-36ca109a9d71 | 6d72f278-d15b-473e-a0d1-9f483b4c2201 | 2017-07-26 | Warnings | 48e7b70c-97f4-410d-a299-36ca109a9d71 6d72f278-d15b-473e-a0d1-9f483b4c2201 |
Adverse event summaries are temporarily unavailable. Other product information remains available.