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NDC 70512-0101-30 Hydrocortisone Cream 1% 10 mg/g Details

Hydrocortisone Cream 1% 10 mg/g

Hydrocortisone Cream 1% is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by SOLA 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: 70512-0101-30
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Hydrocortisone Topical

Product Information

NDC	70512-0101
Product ID	70512-101_e314cc52-3f73-9a9c-e053-2a95a90a3f4a
Associated GPIs	90550075103720
GCN Sequence Number	015189
GCN Sequence Number Description	hydrocortisone acetate CREAM (G) 1 % TOPICAL
HIC3	Q5P
HIC3 Description	TOPICAL ANTI-INFLAMMATORY STEROIDAL
GCN	30841
HICL Sequence Number	002863
HICL Sequence Number Description	HYDROCORTISONE ACETATE
Brand/Generic	Generic
Proprietary Name	Hydrocortisone Cream 1%
Proprietary Name Suffix	n/a
Non-Proprietary Name	Hydrocortisone Cream 1%
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	10
Active Ingredient Units	mg/g
Substance Name	HYDROCORTISONE
Labeler Name	SOLA 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	2023-12-31

Package

Package Images

NDC 70512-0101-30 (70512010130)

Pricing Information
NDC Package Code	70512-101-30
Billing NDC	70512010130
Package	1 TUBE in 1 CARTON (70512-101-30) / 30 g in 1 TUBE
Marketing Start Date	2020-04-16
NDC Exclude Flag	N
Price Per Unit	0.0588
Pricing Unit	GM
Effective Date	2024-02-21
NDC Description	HYDROCORTISONE 1% CREAM
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 a36b9275-fc3f-106a-e053-2a95a90a3beb Details

Active Ingredient

Hydrocortisone 1%

Purpose

Antipruritic (Anti-itch)

Uses

Relieves itches and rashes due to:

Eczema
Psoriasis
Seborrheic dermatitis
Poison ivy
Poison oak
Poison sumac
Insect bites
External anal itching
Soaps
Detergents
Cosmetics
Jewelry

Temporary relief of external anal and genital itching.

Other use of the product should only be under the advice and supervision of a doctor.

Warnings

For external use only

Do not use:

In the eyes
For diaper rash
If you have vaginal discharge
More than the recommended dosage

Ask doctor before use:

If you are pregnant or breast feeding

Stop use and ask a doctor if:

Condition worsens, or is symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor.

When using this product:

Do not put this product into rectum by using fingers or any mechanical device or applicator.

SPL UNCLASSIFIED SECTION

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away

Directions

Adults and children over 2 years of age - Apply to affected area not more than 3-4 times per day.
Children under 2 years of age - Do not use. Consult a doctor.
- For external anal itching Adults - When practical cleanse the affcted area with mild soap and water and rinse thoroughly. Gently dry patting with bathroom tissue or soft cloth before applying. Apply to affected area not more than 3-4 times per day. Children under 12 years of age: consult a doctor.

Other Information

store between 20ºC and 25ºC (68ºFk and 77ºF)
avoid excessive heat and humidity

Inactive Ingredients

Cetomacrogol 1000, Cetostearyl alcohol, Chlorocresol, Disodium EDTA, Liquid paraffin, Propylene glycol, Purified water, Sodium metabisulphite, White soft paraffin.

PRINCIPAL DISPLAY PANEL

Questions of comments? Call 1-866-747-7365

Manufactured for : SOLA Pharmaceuticals

Baton Rouge, LA 70810

Store in a dry, cool place

Hydrocortisone 1% Cream

NDC 70512-101-30

Qty: 28.4g

INGREDIENTS AND APPEARANCE

HYDROCORTISONE CREAM 1%

hydrocortisone cream 1% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70512-101
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	10 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
PETROLATUM (UNII: 4T6H12BN9U)
CETETH-20 (UNII: I835H2IHHX)
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)
CHLOROCRESOL (UNII: 36W53O7109)
MINERAL OIL (UNII: T5L8T28FGP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70512-101-30	1 in 1 CARTON	04/16/2020
1		30 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	04/16/2020

Labeler - SOLA Pharmaceuticals (080121345)

Revised: 7/2022

Document Id: e314cc52-3f73-9a9c-e053-2a95a90a3f4a

Set id: a36b9275-fc3f-106a-e053-2a95a90a3beb

Version: 4

Effective Time: 20220705