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NDC 63187-0575-01 Hydrocortisone 0.5 g/100g Details

Hydrocortisone 0.5 g/100g

Hydrocortisone is a TOPICAL CREAM 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: 63187-0575-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Hydrocortisone Topical

Product Information

NDC	63187-0575
Product ID	63187-575_4b3ad633-5de0-445f-bbe1-452ca2c1c006
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Hydrocortisone
Proprietary Name Suffix	n/a
Non-Proprietary Name	Hydrocortisone
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	0.5
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 63187-0575-01 (63187057501)

Pricing Information	N/A
NDC Package Code	63187-575-01
Billing NDC	63187057501
Package	1 TUBE in 1 CARTON (63187-575-01) / 28.4 g in 1 TUBE
Marketing Start Date	2018-12-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL ccb62898-b614-45b9-95ea-23e5e31893a8 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Hydrocortisone 0.5%

Purpose

Anti-itch cream

Uses

•

temporary relief of itching associated with minor skin irritations and rashes due to

•: eczema
•: insect bites
•: poison ivy, poison oak, or poison sumac
•: soaps
•: detergents
•: cosmetics
•: jewelry
•: seborrheic dermatitis
•: psoriasis
•: external genital 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

•: in the eyes
•: by putting this product into the rectum by using fingers or any mechanical device or applicator

Ask a doctor before use if you have

•: a vaginal discharge
•: rectal bleeding
•: diaper rash

When using this product consult a doctor before exceeding recommended dosage

Stop use and ask a doctor if

•: condition gets worse
•: condition persists for more than 7 days
•: condition clears up and occurs again within a few days. Do not begin to use any other hydrocortisone product unless you have consulted a doctor.

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, cleanse 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 application of this product

Children under 12 years of age: consult a doctor

Other information

•: To open: unscrew cap, pull tab to remove foil seal, and screw cap back onto tube
•: store at room temperature
•: see carton or tube crimp for lot number and expiration date

Inactive ingredients

aloe barbadensis, cetostearyl alcohol, citric acid, glycerin, glyceryl stearate, methylparaben, mineral oil, paraffin, propylparaben, purified water, sodium cetearyl sulfate, sodium lauryl sulfate, stearyl alcohol

Questions?

Call 1-866-923-4914

SPL UNCLASSIFIED SECTION

Distributed by:

Taro Pharmaceuticals U.S.A., Inc.

Hawthorne, NY 10532

Relabeled by:

Proficient Rx LP

Thousand Oaks, CA 91320

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

Itch and Rash Relief

Sensitive Skin

Hydrocortisone ½%

Cream

Antipruritic (Anti-Itch)

With Aloe

NET WT 1 oz (28.4 g)

INGREDIENTS AND APPEARANCE

HYDROCORTISONE

hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63187-575(NDC:51672-2010)
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Hydrocortisone (UNII: WI4X0X7BPJ) (Hydrocortisone - UNII:WI4X0X7BPJ)	Hydrocortisone	0.5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
cetostearyl alcohol (UNII: 2DMT128M1S)
citric acid monohydrate (UNII: 2968PHW8QP)
glycerin (UNII: PDC6A3C0OX)
glyceryl monostearate (UNII: 230OU9XXE4)
methylparaben (UNII: A2I8C7HI9T)
mineral oil (UNII: T5L8T28FGP)
paraffin (UNII: I9O0E3H2ZE)
propylparaben (UNII: Z8IX2SC1OH)
water (UNII: 059QF0KO0R)
sodium cetostearyl sulfate (UNII: 7ZBS06BH4B)
sodium lauryl sulfate (UNII: 368GB5141J)
stearyl alcohol (UNII: 2KR89I4H1Y)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63187-575-01	1 in 1 CARTON	12/01/2018
1		28.4 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	09/13/2001

Labeler - Proficient Rx LP (079196022)

Name	Address	ID/FEI	Business Operations
Establishment
Proficient Rx LP		079196022	REPACK(63187-575) , RELABEL(63187-575)

Revised: 1/2021

Document Id: 4b3ad633-5de0-445f-bbe1-452ca2c1c006

Set id: ccb62898-b614-45b9-95ea-23e5e31893a8

Version: 3

Effective Time: 20210101

Search by Drug Name or NDC

NDC 63187-0575-01 Hydrocortisone 0.5 g/100g Details

Hydrocortisone 0.5 g/100g

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 63187-0575-01 (63187057501)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL ccb62898-b614-45b9-95ea-23e5e31893a8 Details

SPL UNCLASSIFIED SECTION

Active ingredient

Purpose

Uses

Warnings

Do not use

Ask a doctor before use if you have

Stop use and ask a doctor if

Directions

For external anal itching:

Other information

Inactive ingredients

Questions?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

INGREDIENTS AND APPEARANCE

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