Indications and uses
for the temporary relief of itching associated with minor skin irritations and rashes.
H Plus Holdings
- Manufacturer
- Prime Enterprises
- Effective date
- 2021-10-26
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 23:44:31
Label at a glance#
ProductH Plus Holdings Nourishing
Active ingredientHYDROCORTISONE
Label structure10 sections
Dosage and administration
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.
Label contents#
Full prescribing information#
Active Ingredients
Hydrocortisone acetate 1%
Purpose
Antipuritic (Anti-Itch)
Uses
- for the temporary relief of itching associated with minor skin irritations and rashes.
Warnings
For external use only.
OTC - WHEN USING SECTION
Avoid contact wih the eyes.
OTC - ASK DOCTOR SECTION
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.
Keep out of reach of children. If swallowed, get medical help or contact a Posion Control Center right away.
Directions
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.
Inactive Ingredients
4-Terpineol, Acrylates Copolymer, Allantoin, Benzyl Alcohol, BHT, Butylene Glycol, Caprylic/Capric Triglyceride, Citric Acid, Cocamidopropyl Betaine, Decyl Glucoside, Disodium EDTA, Ethylhexylglycerin, Fragrance, Glycereth-26, Glycerin, Glycol Stearate, Guar Hydroxypropyltrimonium Chloride, Isomalt, Isopropyl Palmitate, Lactic Acid, Lecithin, Menthol, Methylpropanediol, Phenoxyethanol, Poloxamer 407, Polyglyceryl-4 Laurate, Rhododendron Ferrugineum Leaf Cell Culture Extract, Salicylic Acid, Salix Alba (Willow) Bark Extract, Sea Whip Extract, Sodium Cocoyl Isethionate, Sodium Hydroxide, Sodium Lauroamphoacetate, Sodium Lauroyl Methyl Isethionate, Sodium Methyl Cocoyl Taurate, Water
Hair Sanity Anti-Itch Shampoo Step 1 - 3 Fl. Oz.
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| HYDROCORTISONE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 58443-0412-3 | 2024-01-30 | C162847 | 48780-1 | 1030e365-543f-111a-e063-dadaa90a10e2 | H Plus 1.0% Hydrocortisone Nourishing Shampoo 3 Fl. Oz. |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58443-0412-3 | H Plus HoldingsNourishing | 89 mL in 1 TUBE | SHAMPOO | 89 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 58443-0412 | H PLUS HOLDINGS NOURISHING (HYDROCORTISONE ACETATE) SHAMPOO [PRIME ENTERPRISES] | 1 | Legacy NDC, 1 package rows | 20211028_cecfd5ea-929d-7fe6-e053-2a95a90a06f4.zip |
Products#
Every source-derived product name is available through these pages.
- H Plus Holdings Nourishing
- Hydrocortisone Acetate
- BENZYL ALCOHOL
- CITRIC ACID MONOHYDRATE
- ISOPROPYL PALMITATE
- MENTHOL
- WATER
- BUTYLENE GLYCOL
- COCAMIDOPROPYL BETAINE
- DECYL GLUCOSIDE
- LECITHIN, SOYBEAN
- POLOXAMER 407
- WILLOW BARK
- PSEUDOPTEROGORGIA ELISABETHAE
- SODIUM LAUROAMPHOACETATE
- ETHYLHEXYLGLYCERIN
- GLYCERETH-26
- GLYCERIN
- RHODODENDRON FERRUGINEUM LEAF
- BUTYLATED HYDROXYTOLUENE
- 4-TERPINEOL, (+/-)-
- ALLANTOIN
- METHYLPROPANEDIOL
- SODIUM LAUROYL METHYL ISETHIONATE
- PHENOXYETHANOL
- SALICYLIC ACID
- SODIUM COCOYL ISETHIONATE
- SODIUM METHYL COCOYL TAURATE
- LACTIC ACID
- SODIUM HYDROXIDE
- GLYCOL STEARATE
- GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)
- ISOMALT
- MEDIUM-CHAIN TRIGLYCERIDES
- EDETATE DISODIUM ANHYDROUS
- HYDROCORTISONE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 58443-0412 | 58443-0412-3 |
Ingredients#
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| cecfd8d7-9d98-2222-e053-2a95a90afe3e | cecfd5ea-929d-7fe6-e053-2a95a90a06f4 | 2021-10-26 | Warnings | cecfd8d7-9d98-2222-e053-2a95a90afe3e cecfd5ea-929d-7fe6-e053-2a95a90a06f4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.