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NDC 62172-0203-22 DR H STABILIZER 0.75 g/100mL Details

DR H STABILIZER 0.75 g/100mL

DR H STABILIZER is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by DIVERSIFIED MANUFACTURING CORP. 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: 62172-0203-22
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Hydrocortisone Topical

Product Information

NDC	62172-0203
Product ID	62172-203_d60eb88c-a040-6ace-e053-2a95a90a2785
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	DR H STABILIZER
Proprietary Name Suffix	n/a
Non-Proprietary Name	HYDROCORTISONE
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	0.75
Active Ingredient Units	g/100mL
Substance Name	HYDROCORTISONE
Labeler Name	DIVERSIFIED MANUFACTURING CORP
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 62172-0203-22 (62172020322)

Pricing Information	N/A
NDC Package Code	62172-203-22
Billing NDC	62172020322
Package	60 mL in 1 TUBE (62172-203-22)
Marketing Start Date	2016-05-16
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 6a94cdb5-2aca-49a4-bbad-18d9925ea358 Details

ACTIVE INGREDIENT

HYDROCORTISONE 0.75%

PURPOSE

ANTI-ITCH

USES

PROVIDES HELP TO ITCHING ASSOCIATED WITH MINOR SKIN IRRITATION, ECZEMA, PSORIASIS, AND SEBORRHEIC DERMATITIS. OTHER USES OF THIS PRODUCT SHOULD BE UNDER THE ADVICE AND SUPERVISION OF A DOCTOR.

WARNINGS

DISCONTINUE IF CONDITION IS NOT IMPROVING AND CONSULT YOUR PHYSICIAN.

DIRECTIONS

APPLY THIN LAYER TO AFFECTED AREA TWICE DAILY. DO NOT USE FOR MORE THAN 2 WEEKS WITHOUT PHYSICIAN SUPERVISION.

SPL UNCLASSIFIED SECTION

KEEP OUT OF REACH OF CHILDREN.

INACTIVE INGREDIENTS

WATER, PETROLATUM, GLYCERIN, STEARETH-2, DIMETHICONE, CETYL ALCOHOL, MAGNESIUM ALUMINUM SILICATE, BENZYL ALCOHOL, LAURETH-23, SULFUR, CARBOMER, METHYLPARABEN, PROPYLPARABEN, POTASSIUM SORBATE, XANTHAN GUM, SODIUM HYDROXIDE, FRAGRANCE.

OTHER INFORMATION

CONTAINS THE PURE ELEMENT SULFUR AND IS NOT RELATED TO "SULFA ALLERGY".

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DR H STABILIZER

hydrocortisone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:62172-203
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	0.75 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)
PETROLATUM (UNII: 4T6H12BN9U)
GLYCERIN (UNII: PDC6A3C0OX)
STEARETH-2 (UNII: V56DFE46J5)
DIMETHICONE (UNII: 92RU3N3Y1O)
CETYL ALCOHOL (UNII: 936JST6JCN)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
BENZYL ALCOHOL (UNII: LKG8494WBH)
LAURETH-23 (UNII: N72LMW566G)
SULFUR (UNII: 70FD1KFU70)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:62172-203-22	60 mL in 1 TUBE; Type 0: Not a Combination Product	05/16/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	05/16/2016

Labeler - DIVERSIFIED MANUFACTURING CORP (185073996)

Revised: 1/2022

Document Id: d60eb88c-a040-6ace-e053-2a95a90a2785

Set id: 6a94cdb5-2aca-49a4-bbad-18d9925ea358

Version: 6

Effective Time: 20220120