AVEDANA HYDROCORTISONE CREAM WITH ALOE- hydrocortisone cream 
Unipack LLC

----------

Avedana ® Hydrocortisone Cream with Aloe



Drug Facts

Active ingredient

Hydrocortisone, USP 1%

Purpose

Anti-itch

Uses

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

Warnings

For external use only

Do not use

*for external feminine itching if you have a vaginal discharge. Consult a doctor.

*for the treatment of diaper rash. Consult a doctor.

When using this product

*avoid contact with the eyes    *do not begin the use of any other hydrocortisone product unless directed by a doctor

*for external anal itching

    *do not use more than directed unless directed by a doctor

    *do not put this product into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

*symptoms last for more than 7 days    *the condition gets worse    *symptoms clear up and occur again in a few days

*rectal bleeding occurs, consult doctor promptly

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

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

aloe vera concentrate, benzyl alcohol, ceteareth 20, cetearyl alcohol, cetyl palmitate, glycerin, isopropyl myristate, isostearyl neopentanoate, methylparaben, peg-40 stearate, purified water.  May contain citric acid or sodium citrate solution to adjust pH.

Questions?

724-733-7381

Avedana ® Hydrocortisone Cream with Aloe| 1oz Tube label

Tube Label

Avedana ® Hydrocortisone Cream with Aloe| 1oz Carton label

Carton Label

AVEDANA HYDROCORTISONE CREAM WITH ALOE 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43749-620
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE10.2 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43749-620-021 in 1 CARTON04/07/2016
1NDC:43749-620-0128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01704/07/2016
Labeler - Unipack LLC (009248480)
Registrant - Unipack LLC (116015769)
Establishment
NameAddressID/FEIBusiness Operations
Unipack LLC009248480manufacture(43749-620)

Revised: 1/2024
Document Id: 0e23b510-8249-a4c7-e063-6294a90a55b4
Set id: 2a55c426-39b4-4d94-b6b4-6c548c9685e9
Version: 15
Effective Time: 20240104
 
Unipack LLC