Active Ingredients
Hydrocortisone acetate 1%
H Plus Holdings
FDA Label NDC 58443-0412
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Prime Enterprises for the product H Plus Holdings (NDC 58443-0412). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, otc - when using, otc - ask doctor, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Avoid contact wih the eyes.
Otc - Ask Doctor
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.
Principle Display Label (58443 0412 3)
* Please review the disclaimer below.
