Label: AVEDANA HYDROCORTISONE MAXIMUM STRENGTH- hydrocortisone ointment
- NDC Code(s): 43749-250-01, 43749-250-03
- 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.
Updated June 18, 2022
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- 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 genital, 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 soft cloth before applicaion of this product.
Children under 12 years of age: consult a doctor.
- Other information
- Inactive Ingredients
- Avedana® Maximum Strength Hydrocortisone Ointment | 1oz Carton Label
- Avedana® Maximum Strength Hydrocortisone Ointment | 1oz Tube Label
INGREDIENTS AND APPEARANCE
AVEDANA HYDROCORTISONE MAXIMUM STRENGTH
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43749-250 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE 0.0102 g in 1 g Inactive Ingredients Ingredient Name Strength PETROLATUM (UNII: 4T6H12BN9U) MINERAL OIL (UNII: T5L8T28FGP) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43749-250-01 1 in 1 CARTON 02/03/2018 1 NDC:43749-250-03 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 02/03/2018 Labeler - Unipack LLC (009248480) Registrant - Unipack LLC (116015769) Establishment Name Address ID/FEI Business Operations Unipack LLC 009248480 manufacture(43749-250)