HYDROCORTISONE- anti itch ointment

Hydrocortisone by

Drug Labeling and Warnings

Hydrocortisone by is a Otc medication manufactured, distributed, or labeled by NeilMed Pharmaceuticals Inc, NeilMed Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Hydrocortisone, USP 1%

Purpose

Anti-Itch

Uses:

for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:
􀁑 eczema 􀁑 insect bites 􀁑 poison ivy 􀁑 poison oak 􀁑 poison sumac 􀁑 soaps 􀁑 jewelry 􀁑 detergents 􀁑 cosmetics
􀁑 psoriasis 􀁑 seborrheic dermatitis 􀁑 for external genital, feminine 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 external feminine itching if you have a vaginal discharge. Consult a doctor.

􀁑for the treatment of diaper rash. Consult a doctor.

Warnings:

When using this product

􀀃avoid contact with the eyes

􀀃do not begin the use of any other hydrocortisone product unless directed by a doctor

􀀃for external anal itching: 􀁑􀀃do not use more than directed unless directed by a doctor 􀁑􀀃do not put this product into the rectum by using fingers or any mechanical device or applicator.

Stop use and ask a doctor if :

Stop use and ask a doctor if

􀁑􀀃symptoms last for more than 7 days. 􀁑􀀃the condition gets worse 􀁑􀀃symptoms clear up and occur again in a few days 􀁑􀀃rectal bleeding occurs, consult doctor promptly

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. 1-800-222-1222

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, consult a doctor
If pregnant or breast-feeding 􀁑 ask a health professional before use.
For external anal itching
Adults: when practical, clean the affected area with mild soap and warm water, 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: consult a doctor

STORAGE AND HANDLING

Storage temperature: not to exceed 30°C (86°F).

Other information

Before using any medication, read all label directions.
Keep carton, it contains important information.

Inactive ingredients

mineral oil, white petrolatum.

SAFE HANDLING WARNING

TAMPER EVIDENT DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HYDROCORTISONE 
anti itch ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13709-316
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	0.0102 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13709-316-01	1 in 1 CARTON	08/17/2023
1		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	08/17/2023

Labeler - NeilMed Pharmaceuticals Inc (799295915)

Establishment
Name	Address	ID/FEI	Business Operations
NeilMed Pharmaceuticals Inc.		799295915	manufacture(13709-316)