ELIXIRCORTIRELIEF- hydrocortisone cream

ElixirCortiRelief by

Drug Labeling and Warnings

ElixirCortiRelief by is a Otc medication manufactured, distributed, or labeled by ELIXIR HEALTHCARE USA, LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient (in each gram)

Hydrocortisone Acetate USP 1% w/w

Purpose

Anti-Itch Cream

Uses

For temporary relief of minor skin irritations, itching and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewellery, for external genital, feminine and anal itching

Warnings

For external use only

Do not use

In the eyes
For diaper rash
If you have vaginal discharge, more then recommended dosage.

Ask a doctor before use in case of

you are pregnant or breast-feeding

Stop use and ask a doctor if

the condition worsens or if 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 over 2 years of age
Apply evenly to affected area no more than 3 to 4 times daily
Children under 2 years of age.Do not use. Consult a doctor.
Adults.When practical, Clean the affected area with mild soap and warm water and rinse thoroughly. Gently dry, patting or blotting with bathroom tissue or soft cloth before applying. Apply externally to the area upto 6 times daily or after each bowel movement. After application, discard pad. Do not flush in toilet.

Inactive ingredients

Cetomacrogol-1000, Cetostearyl Alcohol, Chlorocresol, Edetate Disodium, Liquid Paraffin, Propylene Glycol, Purified Water, Sodium Metabisulphite, White Soft Paraffin.

Other information

Store at 20°-25°C (68°-77°F)
avoid excessive heat and humidity

PRINCIPAL DISPLAY PANEL

Reorder No. xxxx

Elixir

Hydrocortisone Cream 1%

Anti-Itch Cream

Net Wt. 1 OZ. (28.3G)

PRINCIPAL DISPLAY PANEL

Elixir

Hydrocortisone Cream 1%

Anti-Itch Cream

Maximum Strength

16 oz (454 g)

24 Jars

itching and rashes

Relief of minor skin irritation

NDC: 84546-0005-01

Net Wt. 16 OZ. 9454G)

Reorder No:

MPR-XXXXX

INGREDIENTS AND APPEARANCE

ELIXIRCORTIRELIEF 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84546-0005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CHLOROCRESOL (UNII: 36W53O7109)
EDETATE DISODIUM (UNII: 7FLD91C86K)
MINERAL OIL (UNII: T5L8T28FGP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84546-0005-1	1 in 1 CARTON	12/31/2025
1		28.3 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 84546-0005-2	24 in 1 CASE	12/31/2025
2		454 g in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	12/31/2025

Labeler - ELIXIR HEALTHCARE USA, LLC. (084920892)

Registrant - ELIXIR HEALTHCARE USA, LLC. (084920892)