Label: AVEDANA HYDROCORTISONE CREAM WITH ALOE- hydrocortisone cream
- NDC Code(s): 43749-620-01, 43749-620-02
- Packager: Unipack 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 June 18, 2022
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:
*eczema *insect bites *poison ivy *poison oak *poison sumac *soaps
*jewelry *detergents *cosmetics *psoriasis *seborrheic dermatitis
*for external gential, feminine and anal itching *other uses of this product should be only under the advice and supervision of a doctor
- Do not use
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
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 *do not use, consult a doctor
For external anal itching
Adults: when practical, clean the affected area with mild soap and warm water, rinse thoroughly, gently dry by patting or blotting with toilet tissue or a solft cloth before application of this product.
Children under 12 years of age: consult a doctor
- Other information
- Inactive ingredients
- Avedana ® Hydrocortisone Cream with Aloe| 1oz Tube label
- Avedana ® Hydrocortisone Cream with Aloe| 1oz Carton label
INGREDIENTS AND APPEARANCE
AVEDANA HYDROCORTISONE CREAM WITH ALOE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43749-620 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE 10.2 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETYL PALMITATE (UNII: 5ZA2S6B08X) ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q) METHYLPARABEN (UNII: A2I8C7HI9T) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) PEG-40 STEARATE (UNII: ECU18C66Q7) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) BENZYL ALCOHOL (UNII: LKG8494WBH) ALOE VERA LEAF (UNII: ZY81Z83H0X) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43749-620-02 1 in 1 CARTON 04/07/2016 1 NDC:43749-620-01 28 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 04/07/2016 Labeler - Unipack LLC (009248480) Registrant - Unipack LLC (116015769) Establishment Name Address ID/FEI Business Operations Unipack LLC 009248480 manufacture(43749-620)