CORTIZONE 10 WATER RESISTANT- hydrocortisone ointment

Cortizone 10 Water Resistant by

Drug Labeling and Warnings

Cortizone 10 Water Resistant by is a Otc medication manufactured, distributed, or labeled by Chattem, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Cortizone 10
Ointment

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 ■ cosmetics

    ■ soaps ■ seborrheic dermatitis

■ temporarily relieves external anal and genital itching

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

Warnings

For external use only

Do not use

■ in the genital area if you have a vaginal discharge. Consult a doctor. ■ for the treatment of diaper rash. Consult a doctor.

When using this product

■ avoid contact with eyes ■ do not use more than directed unless told to do so by a doctor ■ do not put directly 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, and do not begin use of any other hydrocortisone product unless you have asked a doctor

■ rectal bleeding occurs

Keep out of reach of children. 

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• for itching of skin irritation, inflammation, and rashes:  
  • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 time daily
    
  • children under 2 years of age: ask a doctor
  
  
• for external anal and genital itching, adults:
  • when practical, clean 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 applying
    
  • apply to affected area not more than 3 to 4 times daily 
    
  • children under 12 years of age: ask a doctor

Inactive ingredients

petrolatum

Principal Display Panel

Cortizone 10
WATER RESISTANT OINTMENT
1% Hydrocortisone
Anti-Itch Ointment
Net wt 1 oz (28 g)

INGREDIENTS AND APPEARANCE

CORTIZONE 10 WATER RESISTANT 
hydrocortisone ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-0344
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
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-0344-5	1 in 1 CARTON	01/01/2023
1		56 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 41167-0344-0	1 in 1 CARTON	01/01/2023
2		28 g in 1 TUBE; 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	01/01/2023

Labeler - Chattem, Inc. (003336013)