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NDC 51672-2013-03 Hydrocortisone 1 g/100g Details

Hydrocortisone 1 g/100g

Hydrocortisone is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Taro Phamaceuticals U.S.A., Inc.. 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: 51672-2013-03
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Hydrocortisone Topical

Product Information

NDC	51672-2013
Product ID	51672-2013_546a3631-8018-4433-a1fa-922626494ef8
Associated GPIs	90550075003720
GCN Sequence Number	016266
GCN Sequence Number Description	hydrocortisone/aloe vera CREAM (G) 1 % TOPICAL
HIC3	Q5P
HIC3 Description	TOPICAL ANTI-INFLAMMATORY STEROIDAL
GCN	92421
HICL Sequence Number	003289
HICL Sequence Number Description	HYDROCORTISONE/ALOE VERA
Brand/Generic	Generic
Proprietary Name	Hydrocortisone
Proprietary Name Suffix	with Aloe
Non-Proprietary Name	Hydrocortisone
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	1
Active Ingredient Units	g/100g
Substance Name	HYDROCORTISONE
Labeler Name	Taro Phamaceuticals U.S.A., Inc.
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 51672-2013-03 (51672201303)

Pricing Information	N/A
NDC Package Code	51672-2013-3
Billing NDC	51672201303
Package	1 TUBE in 1 CARTON (51672-2013-3) / 60 g in 1 TUBE
Marketing Start Date	2020-07-17
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL caa2fd64-e262-4d7c-ad8a-69f506feba8c Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Hydrocortisone 1%

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

Questions?

Call 1-866-923-4914

SPL UNCLASSIFIED SECTION

Distributed by:

Taro Pharmaceuticals U.S.A., Inc.

Hawthorne, NY 10532

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

Itch and Rash Relief

MAXIMUM STRENGTH

Hydrocortisone 1%

Cream

Antipruritic (Anti-Itch)

With Aloe

NET WT 1 oz (28.4 g)

Principal Display Panel - 28.4 g Tube Carton

INGREDIENTS AND APPEARANCE

HYDROCORTISONE WITH ALOE

hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51672-2013
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
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
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)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:51672-2013-1	1 in 1 CARTON	08/23/1995
1		14.2 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:51672-2013-2	1 in 1 CARTON	08/23/1995
2		28.4 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC:51672-2013-3	1 in 1 CARTON	07/17/2020
3		60 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	08/23/1995

Labeler - Taro Phamaceuticals U.S.A., Inc. (145186370)

Name	Address	ID/FEI	Business Operations
Establishment
Taro Phamaceuticals Inc.		206263295	MANUFACTURE(51672-2013)

Revised: 7/2020

Document Id: 546a3631-8018-4433-a1fa-922626494ef8

Set id: caa2fd64-e262-4d7c-ad8a-69f506feba8c

Version: 3

Effective Time: 20200729

Search by Drug Name or NDC

NDC 51672-2013-03 Hydrocortisone 1 g/100g Details

Hydrocortisone 1 g/100g

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 51672-2013-03 (51672201303)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL caa2fd64-e262-4d7c-ad8a-69f506feba8c 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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