HYDROCORTISONE- anti itch ointment 
NeilMed Pharmaceuticals Inc

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NeilMed Hydrocortisone Ointment Anti Itch 1 Oz

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 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.

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

Hydrocortisone Ointment

HYDROCORTISONE 
anti itch ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13709-316
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE0.0102 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13709-316-011 in 1 CARTON08/17/2023
128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01708/17/2023
Labeler - NeilMed Pharmaceuticals Inc (799295915)
Establishment
NameAddressID/FEIBusiness Operations
NeilMed Pharmaceuticals Inc.799295915manufacture(13709-316)

Revised: 7/2024
Document Id: 1ce22733-8f6f-d7ea-e063-6294a90aa49b
Set id: 031957e1-9b0c-1579-e063-6394a90aaee8
Version: 3
Effective Time: 20240710
 
NeilMed Pharmaceuticals Inc