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NDC 00904-7623-31 Hydrocortisone with Aloe 1 g/100g Details

Hydrocortisone with Aloe 1 g/100g

Hydrocortisone with Aloe is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Major Pharmaceuticals. 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: 00904-7623-31
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Hydrocortisone Topical

Product Information

NDC	00904-7623
Product ID	0904-7623_3e805912-e5f4-4542-9c12-c4b2212683fa
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 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	Major Pharmaceuticals
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	n/a

Package

Package Images

NDC 00904-7623-31 (00904762331)

Pricing Information
NDC Package Code	0904-7623-31
Billing NDC	00904762331
Package	1 TUBE in 1 CARTON (0904-7623-31) / 28 g in 1 TUBE
Marketing Start Date	2009-04-21
NDC Exclude Flag	N
Price Per Unit	0.04967
Pricing Unit	GM
Effective Date	2022-01-19
NDC Description	HYDROCORTISONE-ALOE 1% CREAM
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1, 5
Classification for Rate Setting	G
As of Date	2022-02-02

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 8d46866e-a3a1-47a0-870b-4272f1522a98 Details

Drug Facts

Active ingredient

Hydrocortisone, USP 1%

Purpose

Anti-itch

Uses

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

eczema
insect bites
poison ivy
poison oak
poison sumac
soaps
jewelry
detergents
cosmetics
psoriasis
seborrheic dermatitis
for external genital, feminine 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

for external feminine itching if you have a vaginal discharge. Consult a doctor.
for the treatment of diaper rash. Consult a doctor.

When using this product

avoid contact with the eyes
do not begin the use of any other hydrocortisone product unless directed by a doctor
for external anal itching:
- do not use more than directed unless directed by a doctor
- do not put this product into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

symptoms last for more than 7 days
the condition gets worse
symptoms clear up and occur again in a few days
rectal bleeding occurs, consult doctor promptly

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, clean the affected area with mild soap and warm water, 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

Store at room temperature 59°-86°F (15°-30°C). Protect from freezing.
Before using any medication, read all label directions. Keep carton, it contains important information.

Inactive ingredients

aloe vera concentrate, cetyl alcohol, glyceryl stearate, isopropyl myristate, methylparaben, polyoxyl 40 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sorbic acid, sorbitan monostearate, stearyl alcohol, white wax. May contain citric acid or sodium citrate solution to adjust pH.

Questions?

1-888-838-2872 between 9 am and 5 pm ET, Monday–Friday.

PRINCIPAL DISPLAY PANEL

Major®

NDC 0904-7623-31

Maximum Strength

Hydrocortisone • 10

Hydrocortisone Cream, USP 1%

antipruritic (anti-itch) cream With Aloe

Temporary Relief of Itching and Rashes Due To:

•Insect Bites   •Eczema   •Soaps

•Poison Ivy, Oak, Sumac •Seborrheic Dermatitis  •Cosmetics

•Psoriasis   •Jewelry   •Detergents

Compare to the Active Ingredient in Cortizone • 10®*

NET WT 1 OZ (28 g)

INGREDIENTS AND APPEARANCE

HYDROCORTISONE WITH ALOE MAXIMUM STRENGTH

hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0904-7623
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)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SORBIC ACID (UNII: X045WJ989B)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
WHITE WAX (UNII: 7G1J5DA97F)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0904-7623-31	1 in 1 CARTON	04/21/2009
1		28 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	04/21/2009	01/31/2025

Labeler - Major Pharmaceuticals (191427277)

Revised: 10/2022

Document Id: 3e805912-e5f4-4542-9c12-c4b2212683fa

Set id: 8d46866e-a3a1-47a0-870b-4272f1522a98

Version: 8

Effective Time: 20221027