HYDROCORTISONE- hydrocortisone lotion
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 Lotion

Drug Facts

Active Ingredient:

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 if product appears to be tampered with.

Do not use:

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

Not for prolonged use. Do not apply to large areas of the body.

Stop use and ask veterinarian

if redness, irritation, or swelling persists or increases.

Directions

• pre-bathe animal with a mild shampoo and dry thoroughly

• if necessary, spread coat apart with fingers to expose irritated area to expose skin

• massage lotion directly on the affected area. only a thin coat is necessary

• small applications at frequent intervals give best results

• for long haired breeds, it may be necessary to clip hair from irritated area to expose skin

• when using this product- avoid in contact with the eyes.

• individual results may vary

Other information

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

Inactive Ingredients

Deionized Water, Mineral Oil, Propylene Glycol, Isopropyl Myristate, Stearic Acid, Beeswax White, Cetyl Alcohol, Cocoamide DEA, Aloe Barbadensis Leal Juice, Carbomer, Sodium Borate, Diazolidinyl Urea, Methylparaben, Propylparaben, Fragrance.

Questions

(800) 530-2178

Package Labeling:

label7

HYDROCORTISONE
hydrocortisone lotion

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC:60754-925
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)
MINERAL OIL (UNII: T5L8T28FGP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
STEARIC ACID (UNII: 4ELV7Z65AP)
WHITE WAX (UNII: 7G1J5DA97F)
CETYL ALCOHOL (UNII: 936JST6JCN)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER 1342 (UNII: 809Y72KV36)
SODIUM BORATE (UNII: 91MBZ8H3QO)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:60754-925-04	118 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: a9e306bd-5b05-4243-bd2b-067da3c2e73c

Set id: 9ab06d29-c595-4e8b-b351-096ae69aa6c4

Version: 11

Effective Time: 20211028

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