HYDROCORTISONE- hydrocortisone shampoo
Twenty-First Century Healthcare Fund, L.L.C.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Hydrocortisone Shampoo

Drug Facts

Active Ingredients:

Hydrocortisone Acetate 0.50%

Purpose

Anti-itch

Uses:

to soothe: • itching • flea bites • dermatitis • skin irritations • eczema

Warnings

For external use only. Use for all adult dogs.

Keep Out of Reach of Children

and animals to avoid unintended consumption.

Do not use:

• in eyes or nose •where infection (pus) is present, since the drug may allow infection to be spread •on pregnant animals.

• if product appears to be tampered with. Not for prolonged use.

Stop use and ask veterinarian

if redness, irritation, or swelling persists or increases.

Directions

• rinse pet with warm water until coat is thoroughly wet

• massage shampoo thoroughly into the coat

• continue massaging and add water during the process to make sure the shampoo is thoroughly distributed through the coat

• leave the pet in lather for 5-10 minutes keeping the pet warm and out of drafts

• rinse thoroughly and dry

• for best results use at least twice a week or as directed by a veterinarian

• Individual result may vary

Other information

Store product in cool. dry place. Avoid temperatures above 86F.

Inactive Ingredients

Deionized Water, Sodium Lauryl Ether Sulfate, Acrylates Copolymer, Cocamidopropyl Betaine. Cocamidopropylamine Oxide, PEG-3 Distearate,

Aloe Barbadensis Leal Juice, Lauryl Glucoside, Triethanolamine. Lactic Acid, DMDM Hydantoin, Methylparaben, Propylparaben, Fragrance.

Questions

(800) 530-2178

Label

label5

HYDROCORTISONE
hydrocortisone shampoo

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC:60754-920
Route of Administration	Topical

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE ACETATE	5 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
SODIUM LAURETH-2 SULFATE (UNII: ZZQ59TY3KG)
METHACRYLATE/METHOXY PEG-10 MALEATE/STYRENE COPOLYMER (UNII: 39DK5WQ2PR)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)
PEG-3 DISTEARATE (UNII: 8420ECX438)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
TROLAMINE (UNII: 9O3K93S3TK)
LACTIC ACID (UNII: 33X04XA5AT)
DMDM HYDANTOIN (UNII: BYR0546TOW)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:60754-920-08	237 mL in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		02/06/2014	04/30/2020

Labeler - Twenty-First Century Healthcare Fund, L.L.C. (081289135)

Revised: 10/2021

Document Id: 8083de36-96ec-40ad-a0a5-82430b5158b6

Set id: a7e9ab8d-6a46-458e-98da-149a3915df44

Version: 12

Effective Time: 20211028

Twenty-First Century Healthcare Fund, L.L.C.