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NDC 41415-0047-75 Publix 1 g/100g Details

Publix 1 g/100g

Publix is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Publix Super Markets 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: 41415-0047-75
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Hydrocortisone Topical

Product Information

NDC	41415-0047
Product ID	41415-047_95ac798c-931c-4e70-897f-e6b56a569c52
Associated GPIs	48300010000510 90550075003720
GCN Sequence Number	002689
GCN Sequence Number Description	calcium carbonate TAB CHEW 200(500)MG ORAL
HIC3	D4B
HIC3 Description	ANTACIDS
GCN	07893
HICL Sequence Number	001163
HICL Sequence Number Description	CALCIUM CARBONATE
Brand/Generic	Generic
Proprietary Name	Publix
Proprietary Name Suffix	Hydro
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	Publix Super Markets 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 41415-0047-75 (41415004775)

Pricing Information	N/A
NDC Package Code	41415-047-75
Billing NDC	41415004775
Package	1 TUBE in 1 CARTON (41415-047-75) / 28.4 g in 1 TUBE
Marketing Start Date	2009-01-23
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 29296b0f-0eed-4bb9-8727-c25c2bcf9fd6 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

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY PUBLIX

SUPER MARKETS, INC.

3300 PUBLIX CORPORATE

PARKWAY

LAKELAND, FL 33811

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

Publix

hydrocream

1% HYDROCORTISONE

ANTIPRURITIC (ANTI-ITCH)

EFFECTIVE ITCH & RASH RELIEF WITH ALOE

NET WT 1 OZ (28.4 g)

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

INGREDIENTS AND APPEARANCE

PUBLIX HYDRO

hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41415-047
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 lauryl sulfate (UNII: 368GB5141J)
sodium cetostearyl sulfate (UNII: 7ZBS06BH4B)
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:41415-047-75	1 in 1 CARTON	01/23/2009
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	08/23/1995

Labeler - Publix Super Markets Inc (006922009)

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

Name	Address	ID/FEI	Business Operations
Establishment
Taro Phamaceuticals Inc.		206263295	MANUFACTURE(41415-047)

Revised: 12/2021

Document Id: 95ac798c-931c-4e70-897f-e6b56a569c52

Set id: 29296b0f-0eed-4bb9-8727-c25c2bcf9fd6

Version: 3

Effective Time: 20211202

Search by Drug Name or NDC

NDC 41415-0047-75 Publix 1 g/100g Details

Publix 1 g/100g

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 41415-0047-75 (41415004775)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 29296b0f-0eed-4bb9-8727-c25c2bcf9fd6 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

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

INGREDIENTS AND APPEARANCE

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