HEALTHY ACCENTS CORTISONE MAXIMUM STRENGTH- hydrocortisone cream 
DZA Brands 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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DZA Brands, LLC Cortisone Cream Drug Facts

Active ingredient

Hydrocortisone 1%

Purpose

Anti-itch

Uses

•
temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
•
eczema
•
psoriasis
•
poison ivy, oak, sumac
•
insect bites
•
detergents
•
jewelry
•
seborrheic dermatitis
•
soaps
•
external genital 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 the treatment of diaper rash. Ask a doctor.
•
for external genital itching if you have a vaginal discharge. Ask a doctor.

When using this product

•
avoid contact with the eyes
•
do not begin use of any other hydrocortisone product unless you have asked a doctor
•
for external anal itching do not exceed the recommended daily dosage unless directed by a doctor. In case of bleeding, consult a doctor promptly.
•
do not put this product into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

•
condition worsens
•
symptoms persist for more than 7 days or clear up and occur again within a few days

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. Ask a doctor.

for external anal itching:

•
adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.

children under 12 years of age with external anal itching: ask a doctor

Other information

•
store at 20°-25°C (68°-77°F)

Inactive ingredients

aloe vera gel, ceteareth-20, cetearyl alcohol, cetyl palmitate, glycerin, isopropyl myristate, isostearyl neopentanoate, methylparaben, purified water

Questions or comments?

1-866-322-2439

Principal Display Panel

Compare to Cortaid® active ingredient

maximum strength

cortisone cream

anti-itch cream with aloe

hydrocortisone 1%

NET WT 1 OZ (28g)

Cortisone Cream Carton Image 1
Cortisone Cream Carton Image 2
HEALTHY ACCENTS CORTISONE  MAXIMUM STRENGTH
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55316-541
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETYL PALMITATE (UNII: 5ZA2S6B08X)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55316-541-641 in 1 CARTON08/25/201010/31/2020
128 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 finalpart34808/25/201010/31/2020
Labeler - DZA Brands LLC (090322194)

Revised: 12/2019
Document Id: a2b2448d-6e49-4e03-8e75-c1d600814a17
Set id: 5692eb8b-d09a-48b8-8813-83fe919b8878
Version: 3
Effective Time: 20191211
 
DZA Brands LLC