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NDC 71205-0034-30 Hydrocortisone 1 g/100g Details

Hydrocortisone 1 g/100g

Hydrocortisone is a TOPICAL OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by Proficient Rx LP. The primary component is HYDROCORTISONE.

MedlinePlus Drug Summary

Hydrocortisone topical is used to treat redness, swelling, itching, and discomfort of various skin conditions. Hydrocortisone is in a class of medications called corticosteroids. It works by activating natural substances in the skin to reduce swelling, redness, and itching.

Related Packages: 71205-0034-30
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Hydrocortisone Topical

Product Information

NDC	71205-0034
Product ID	71205-034_b27ef9e6-7c67-4af6-aeef-427cbbe017e2
Associated GPIs	90550075004210
GCN Sequence Number	007547
GCN Sequence Number Description	hydrocortisone OINT. (G) 1 % TOPICAL
HIC3	Q5P
HIC3 Description	TOPICAL ANTI-INFLAMMATORY STEROIDAL
GCN	30951
HICL Sequence Number	002867
HICL Sequence Number Description	HYDROCORTISONE
Brand/Generic	Generic
Proprietary Name	Hydrocortisone
Proprietary Name Suffix	Maximum Strength
Non-Proprietary Name	Hydrocortisone
Product Type	HUMAN OTC DRUG
Dosage Form	OINTMENT
Route	TOPICAL
Active Ingredient Strength	1
Active Ingredient Units	g/100g
Substance Name	HYDROCORTISONE
Labeler Name	Proficient Rx LP
Pharmaceutical Class	Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2024-12-31

Package

Package Images

NDC 71205-0034-30 (71205003430)

Pricing Information	N/A
NDC Package Code	71205-034-30
Billing NDC	71205003430
Package	1 TUBE in 1 CARTON (71205-034-30) / 28 g in 1 TUBE
Marketing Start Date	2018-05-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b7ff20ee-b092-4831-bfe7-517d4c2558e8 Details

Drug Facts

Active ingredient

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.

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

•: 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.

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

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

Other information

•: Store at room temperature 59°-86°F (15°-30°C).
•: Before using any medication, read all label directions. Keep carton, it contains important information.

Inactive ingredients

mineral oil, white petrolatum

Questions?

1-800-432-8534 between 9 am and 4 pm EST, Monday–Friday.

PRINCIPAL DISPLAY PANEL

Distributed by:

Actavis Pharma Inc.

Parsippany, NJ 07054

Relabeled by:

Proficient Rx LP

Thousand Oaks, CA 91320

Proficient Rx

NDC 71205-034-30

Compare to the active ingredient in Cortizone•10®*

Maximum Strength

Hydrocortisone Ointment, USP 1%

Anti-Itch Ointment

Relieves Itches and Rashes

Net wt. 1 oz (28g)

For the temporary relief of itches and rashes due to:

• Insect Bites • Eczema • Seborrheic dermatitis

• Poison Ivy, oak & sumac

INGREDIENTS AND APPEARANCE

HYDROCORTISONE MAXIMUM STRENGTH

hydrocortisone ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71205-034(NDC:0472-0345)
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	1 g in 100 g

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71205-034-30	1 in 1 CARTON	05/01/2018
1		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	07/21/1998

Labeler - Proficient Rx LP (079196022)

Name	Address	ID/FEI	Business Operations
Establishment
Proficient Rx LP		079196022	RELABEL(71205-034)

Revised: 1/2021

Document Id: b27ef9e6-7c67-4af6-aeef-427cbbe017e2

Set id: b7ff20ee-b092-4831-bfe7-517d4c2558e8

Version: 4

Effective Time: 20210101