Label: QUADRYDERN- hydrocortisone cream
- NDC Code(s): 59428-403-57
- Packager: Productos Zapotol Corp
- 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 March 31, 2022
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- ACTIVE INGREDIENT
-
PURPOSE
Uses
- temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to: eczema, psoriasis, jewelry, insect bites, soaps, cosmetics, detergents, seborrheic dermatitis, poison ivy, oak, sumac
- temporarily relieves external anal and genital itching
- other uses of this product should be only under the advice and supervision of a doctor
- WARNINGS
- DO NOT USE
- WHEN USING
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
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INDICATIONS & USAGE
Directions
- for itching of skin irritation, inflammation, and rashes:
- adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.
- children under 2 years of age: ask a doctor
- Adults: for external anal itching:
- for external anal and genital itching, adults:
- when practical, clean the affected area with mild soap and warm water and rinse thoroughly
- gently dry by patting or blotting with toilet tissue or a soft cloth before applying
- apply to affected area not more than 3 to 4 times daily
- children under 12 years of age: ask a doctor
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
QUADRYDERN
hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59428-403 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 SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B) WHITE WAX (UNII: 7G1J5DA97F) ALOE VERA LEAF (UNII: ZY81Z83H0X) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) ICODEXTRIN (UNII: 2NX48Z0A9G) MINERAL OIL (UNII: T5L8T28FGP) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) LIGHT MINERAL OIL (UNII: N6K5787QVP) PETROLATUM (UNII: 4T6H12BN9U) WATER (UNII: 059QF0KO0R) METHYLPARABEN (UNII: A2I8C7HI9T) CALCIUM ACETATE MONOHYDRATE (UNII: 7ZA48GIM5H) SODIUM LAURYL SULFATE (UNII: 368GB5141J) MALTODEXTRIN (UNII: 7CVR7L4A2D) ALUMINIUM SULFATE OCTADECAHYDRATE (UNII: TCS9L00G8F) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59428-403-57 1 in 1 CARTON 03/11/2020 1 57 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 03/11/2020 Labeler - Productos Zapotol Corp (186063850)