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NDC 49348-0441-72 SUNMARK HYDROCORTISONE PLUS 1 g/100g Details

SUNMARK HYDROCORTISONE PLUS 1 g/100g

SUNMARK HYDROCORTISONE PLUS is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Strategic Sourcing Services LLC. 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: 49348-0441-72
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Hydrocortisone Topical

Product Information

NDC	49348-0441
Product ID	49348-441_c7ea187c-b69a-44b8-b0f3-d12197c9c267
Associated GPIs	90559902503720
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	SUNMARK HYDROCORTISONE PLUS
Proprietary Name Suffix	n/a
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	Strategic Sourcing Services LLC
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 49348-0441-72 (49348044172)

Pricing Information
NDC Package Code	49348-441-72
Billing NDC	49348044172
Package	1 TUBE in 1 CARTON (49348-441-72) / 28.4 g in 1 TUBE
Marketing Start Date	1989-10-03
NDC Exclude Flag	N
Price Per Unit	0.09263
Pricing Unit	GM
Effective Date	2024-02-21
NDC Description	SM HYDROCORTISONE PLUS 1% CRM
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1, 5
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL ed6b197d-972a-455d-86be-bf2e8ec12b16 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Hydrocortisone 1%

Purpose

Anti-itch

Uses

for the temporary relief of itching associated with minor skin irritations, inflammation and rashes due to:

eczema
seborrheic dermatitis
psoriasis
insect bites
poison ivy, oak, sumac
soaps
detergents
cosmetics
jewelry
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
avoid contact with the eyes

Stop using this product and ask a doctor

if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
before you begin using any other hydrocortisone product

Do not use this product and ask a doctor

if you have a vaginal discharge
before treating diaper rash
before using on children under 2 years of age

For External Anal Itching Users

do not exceed the recommended daily dosage unless directed by a doctor
in case of bleeding, consult a doctor promptly
do not put this product into the rectum by using fingers or any mechanical device or applicator
children under 12 years of age: consult a doctor

Keep this and all drugs out of the reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Before using any medication, read all label direction. Keep this carton. It contains important information.

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, ask a doctor

For External Anal Itching Users

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

unscrew cap, pull tab to remove foil seal, and screw cap back onto tube
if seal has been broken, do not use this product. Return product to the store where you bought it.
store at controlled room temperature 59°-86°F
see carton or tube crimp for lot number and expiration date

Inactive ingredients

aloe barbadensis, cetearyl alcohol, chamomile (anthemis nobilis) oil, citric acid, corn (zea mays) oil, glycerin, glyceryl stearate, isopropyl palmitate, maltodextrin, methylparaben, mineral oil, paraffin, petrolatum, propylene glycol, propylparaben, purified water, sodium cetearyl sulfate, sodium lauryl sulfate, stearyl alcohol, vitamin A (retinyl palmitate), vitamin D (cholecalciferol), vitamin E (tocopheryl acetate).

SPL UNCLASSIFIED SECTION

Distributed by McKesson

One Post Street

San Francisco, CA 94104

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

sunmark™

hydrocortisone cream 1%

Antipruritic (Anti-Itch)

MAXIMUM STRENGTH PLUS 12 MOISTURIZERS

NET WT 1 OZ (28.4 g)

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

INGREDIENTS AND APPEARANCE

SUNMARK HYDROCORTISONE PLUS

hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49348-441
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)
chamomile flower oil (UNII: 60F80Z61A9)
citric acid monohydrate (UNII: 2968PHW8QP)
corn oil (UNII: 8470G57WFM)
glycerin (UNII: PDC6A3C0OX)
glyceryl monostearate (UNII: 230OU9XXE4)
isopropyl palmitate (UNII: 8CRQ2TH63M)
maltodextrin (UNII: 7CVR7L4A2D)
methylparaben (UNII: A2I8C7HI9T)
mineral oil (UNII: T5L8T28FGP)
paraffin (UNII: I9O0E3H2ZE)
petrolatum (UNII: 4T6H12BN9U)
propylene glycol (UNII: 6DC9Q167V3)
propylparaben (UNII: Z8IX2SC1OH)
water (UNII: 059QF0KO0R)
sodium cetostearyl sulfate (UNII: 7ZBS06BH4B)
sodium lauryl sulfate (UNII: 368GB5141J)
stearyl alcohol (UNII: 2KR89I4H1Y)
Vitamin A palmitate (UNII: 1D1K0N0VVC)
cholecalciferol (UNII: 1C6V77QF41)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:49348-441-72	1 in 1 CARTON	10/03/1989
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	10/03/1989

Labeler - Strategic Sourcing Services LLC (116956644)

Revised: 11/2019

Document Id: c7ea187c-b69a-44b8-b0f3-d12197c9c267

Set id: ed6b197d-972a-455d-86be-bf2e8ec12b16

Version: 3

Effective Time: 20191125

Search by Drug Name or NDC

NDC 49348-0441-72 SUNMARK HYDROCORTISONE PLUS 1 g/100g Details

SUNMARK HYDROCORTISONE PLUS 1 g/100g

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 49348-0441-72 (49348044172)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL ed6b197d-972a-455d-86be-bf2e8ec12b16 Details

SPL UNCLASSIFIED SECTION

Active ingredient

Purpose

Uses

Warnings

Stop using this product and ask a doctor

Do not use this product and ask a doctor

Keep this and all drugs out of the reach of children.

Directions

For External Anal Itching Users

Other information

Inactive ingredients

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

INGREDIENTS AND APPEARANCE

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