Search by Drug Name or NDC

NDC 71101-0211-01 TheraCare Maximum Strength 1% Hydrocortisone 10 mg/g Details

TheraCare Maximum Strength 1% Hydrocortisone 10 mg/g

TheraCare Maximum Strength 1% Hydrocortisone is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Veridian Healthcare. 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: 71101-0211-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Hydrocortisone Topical

Product Information

NDC	71101-0211
Product ID	71101-211_c18159e9-cad3-0384-e053-2995a90af492
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	TheraCare Maximum Strength 1% Hydrocortisone
Proprietary Name Suffix	n/a
Non-Proprietary Name	hydrocortisone
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	10
Active Ingredient Units	mg/g
Substance Name	HYDROCORTISONE
Labeler Name	Veridian Healthcare
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 71101-0211-01 (71101021101)

Pricing Information	N/A
NDC Package Code	71101-211-01
Billing NDC	71101021101
Package	1 TUBE in 1 CARTON (71101-211-01) / 28.3 g in 1 TUBE
Marketing Start Date	2021-05-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL c1815a19-f463-3c12-e053-2995a90a2607 Details

Active Ingredient:

Hydrocortisone 1%

Purpose

Anti-itch

Uses

temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
- eczema
- psoriasis
- poison ivy, oak, sumac
- insect bites
- detergents
- jewelry
- cosmetics
- soaps
- seborrheic dermatitis
- temporarily relieves external anal and genital itching
- other uses of this product should only be under the advice and supervision of a doctor

Warnings

For external use only

Do not use

in the genital area if you have a vaginal discharge.
for the treatment of diaper rash.
with any other hydrocortisone product unless you have asked a doctor

When using this product

use only as directed
avoid contact with eyes
do not use more than directed unless told to do so by a doctor
do not put directly into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

condition worsens, 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
rectal bleeding occurs

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

for itching of skin irritation, inflammation, and rashes:
adults and children 2 years of age and over: apply to affected area not more than 3 to 4 times daily
children under 2 years of age: consult a physician
for external anal and genital itching, adults and children 12 years of age and over:
- when practical, clean 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 applying
- apply to affected area not more than 3 to 4 times daily
- children under 12 years of age: consult a physician

Other information

Store at 20-25C (68-77F)

do not use if tube seal under cap is broken

Inactive Ingredients

cetostearyl alcohol, edetate sodium, glyceryl monostearate, methylparaben, mineral oil, petrolatum, polysorbate 60, propylene glycol, propylparaben, sorbitan monostearate water.

TheraCare Maximum Strength 1% Hydrocortisone Cream

INGREDIENTS AND APPEARANCE

THERACARE MAXIMUM STRENGTH 1% HYDROCORTISONE

hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71101-211
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
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
EDETATE SODIUM (UNII: MP1J8420LU)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71101-211-01	1 in 1 CARTON	05/01/2021
1		28.3 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	05/01/2021

Labeler - Veridian Healthcare (830437997)

Name	Address	ID/FEI	Business Operations
Establishment
Anicare Pharmaceuticals Private Limited		916837425	manufacture(71101-211)

Revised: 5/2021

Document Id: c18159e9-cad3-0384-e053-2995a90af492

Set id: c1815a19-f463-3c12-e053-2995a90a2607

Version: 1

Effective Time: 20210504