H Plus Holdings

Manufacturer
Prime Enterprises, Inc.
Effective date
2021-08-25
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:34:12

Label at a glance#

ProductH Plus Holdings Nourishing
Active ingredientHYDROCORTISONE
Label structure9 sections

Indications and uses

for the temporary relief of itching associated with minor skin irritations and rashes.

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

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone acetate 1%

Purpose

OTC - PURPOSE SECTION

Antipuritic (Anti-Itch)

Uses

INDICATIONS & USAGE SECTION

  • for the temporary relief of itching associated with minor skin irritations and rashes.

Warnings

WARNINGS SECTION

For external use only.

OTC - WHEN USING SECTION

Avoid contact wih the eyes.

If contact occurs, rinse eyes thoroughly with water.

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Posion Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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.

Hair Sanity Anti-Itch Shampoo Step 1

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principle Display LabelPrinciple Display Label

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 36 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58443-041158443-0411-4

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 34 matching rows.

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ca6804e4-8982-4004-e053-2995a90a7508ca62e47e-8cba-e9e1-e053-2a95a90abffb2021-08-25WarningsExact identifier
spl id: ca6804e4-8982-4004-e053-2995a90a7508
spl set id: ca62e47e-8cba-e9e1-e053-2a95a90abffb

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.