Label: PREPARATION H SOOTHING RELIEF ANTI-ITCH- hydrocortisone cream
- NDC Code(s): 0573-0552-11
- Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated July 19, 2022
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
Warnings
For external use only
When using this product
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- avoid contact with the eyes
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- do not exceed the recommended daily dosage unless directed by a doctor
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- do not put into the rectum by using fingers or any mechanical device or applicator
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DOSAGE & ADMINISTRATION
Directions
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- adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or soft cloth before application of this product.
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- when first opening the tube, puncture foil seal with top end of cap
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- adults and children 12 years of age and older: apply to the affected area not more than 3 to 4 times daily
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- children under 12 years of age: do not use, consult a doctor
- STORAGE AND HANDLING
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INACTIVE INGREDIENT
Inactive ingredients
anhydrous citric acid, butylated hydroxyanisole, carboxymethylcellulose sodium, cetyl alcohol, citric acid monohydrate, edetate disodium, glycerin, glyceryl oleate, glyceryl stearate, lanolin, methylparaben, propyl gallate, propylene glycol, propylparaben, purified water, simethicone emulsion, sodium benzoate, sodium lauryl sulfate, stearyl alcohol, white petrolatum, xanthan gum
- QUESTIONS
- PRINCIPAL DISPLAY PANEL - 26 g Tube Label
- PRINCIPAL DISPLAY PANEL - 26 g Tube Carton
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INGREDIENTS AND APPEARANCE
PREPARATION H SOOTHING RELIEF ANTI-ITCH
hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-0552 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE 10 mg in 1 g Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) CETYL ALCOHOL (UNII: 936JST6JCN) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL OLEATE (UNII: 4PC054V79P) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) LANOLIN (UNII: 7EV65EAW6H) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYL GALLATE (UNII: 8D4SNN7V92) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) DIMETHICONE 350 (UNII: 2Y53S6ATLU) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM LAURYL SULFATE (UNII: 368GB5141J) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) PETROLATUM (UNII: 4T6H12BN9U) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color WHITE (off-white viscous cream) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0573-0552-11 1 in 1 CARTON 02/28/2020 1 26 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part348 02/28/2020 Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)