AVEDANA HYDROCORTISONE CREAM WITH ALOE- hydrocortisone cream 
Unipack LLC

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.

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Avedana ® Hydrocortisone Cream with Aloe - Maximum Strength

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:

Warnings

For external use only

Do not use

When using this product

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?

Call 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:43749-621
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETYL PALMITATE (UNII: 5ZA2S6B08X)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
PEG-40 STEARATE (UNII: ECU18C66Q7)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43749-621-011 in 1 CARTON08/27/2021
1NDC:43749-621-0328 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/27/2021
Labeler - Unipack LLC (009248480)
Registrant - Unipack LLC (009248480)
Establishment
NameAddressID/FEIBusiness Operations
Unipack LLC009248480manufacture(43749-621)

Revised: 1/2023
Document Id: f28f8618-610c-7440-e053-2995a90a1f2b
Set id: ca9315f2-d225-d491-e053-2995a90ac893
Version: 3
Effective Time: 20230118
 
Unipack LLC