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NDC 49348-0521-78 Sunmark Hydrocortisone with Aloe 1 g/100g Details

Sunmark Hydrocortisone with Aloe 1 g/100g

Sunmark Hydrocortisone with Aloe 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: 49348-0521-78
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Hydrocortisone Topical

Product Information

NDC	49348-0521
Product ID	49348-521_6927ae99-b678-41a6-b1cb-b548fce8c565
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	Sunmark Hydrocortisone with Aloe
Proprietary Name Suffix	Maximum Strength
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 49348-0521-78 (49348052178)

Pricing Information
NDC Package Code	49348-521-78
Billing NDC	49348052178
Package	1 TUBE in 1 CARTON (49348-521-78) / 60 g in 1 TUBE
Marketing Start Date	2014-05-21
NDC Exclude Flag	N
Price Per Unit	0.03875
Pricing Unit	GM
Effective Date	2023-10-18
NDC Description	SM HYDROCORTISONE-ALOE 1% CRM
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	4, 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 e9180433-4e6e-40d9-807b-1e3dd8c22e0d 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 directions. 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, cetostearyl alcohol, citric acid, glycerin, glyceryl stearate, methylparaben, mineral oil, paraffin, propylparaben, purified water, sodium cetearyl sulfate, sodium lauryl sulfate, stearyl alcohol

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 WITH ALOE

NET WT 1 OZ (28.4 g)

Principal Display Panel - 28.4 g Tube Carton

INGREDIENTS AND APPEARANCE

SUNMARK HYDROCORTISONE WITH ALOE MAXIMUM STRENGTH

hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49348-521
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
aloe vera leaf (UNII: ZY81Z83H0X)
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:49348-521-72	1 in 1 CARTON	05/01/2014
1		28.4 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:49348-521-78	1 in 1 CARTON	05/21/2014
2		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 - Strategic Sourcing Services LLC (116956644)

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

Name	Address	ID/FEI	Business Operations
Establishment
Taro Phamaceuticals Inc.		206263295	MANUFACTURE(49348-521)

Revised: 11/2019

Document Id: 6927ae99-b678-41a6-b1cb-b548fce8c565

Set id: e9180433-4e6e-40d9-807b-1e3dd8c22e0d

Version: 3

Effective Time: 20191125

Search by Drug Name or NDC

NDC 49348-0521-78 Sunmark Hydrocortisone with Aloe 1 g/100g Details

Sunmark Hydrocortisone with Aloe 1 g/100g

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 49348-0521-78 (49348052178)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL e9180433-4e6e-40d9-807b-1e3dd8c22e0d 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

For External Anal Itching Users

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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