HYDROCORTISONE MAXIMUM STRENGTH- hydrocortisone ointment 
Unipack, Inc.

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 ® Maximum Strength Hydrocortisone Ointment

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:

other uses of this product should be only under the advice and supervision of a doctor

Warnings

For external use only

Do not use

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

Children under 2 years of age

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:

Other information

Inactive Ingredients

mineral oil, white petrolatum

Avedana ® Maximum Strength Hydrocortisone Ointment | 1oz Tube Label

Tube Label

Avedana ® Maximum Strength Hydrocortisone Ointment | 1oz Carton Label

Carton Label

HYDROCORTISONE  MAXIMUM STRENGTH
hydrocortisone ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43749-251
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE0.01 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
MINERAL OIL (UNII: T5L8T28FGP)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43749-251-011 in 1 CARTON09/03/2021
1NDC:43749-251-0328 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 finalpart34809/03/2021
Labeler - Unipack, Inc. (009248480)
Registrant - ASIAN AEROSOL OAN PRIVATE LIMITED (872341020)
Establishment
NameAddressID/FEIBusiness Operations
Unipack, Inc.009248480label(43749-251)
Establishment
NameAddressID/FEIBusiness Operations
ASIAN AEROSOL OAN PRIVATE LIMITED872341020manufacture(43749-251)

Revised: 9/2021
Document Id: cb1e7bf4-5d55-5b79-e053-2a95a90a306e
Set id: cb1e7bf4-5d54-5b79-e053-2a95a90a306e
Version: 1
Effective Time: 20210903
 
Unipack, Inc.