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NDC 00113-0471-64 Good Sense Anti Itch 1 g/100g Details

Good Sense Anti Itch 1 g/100g

Good Sense Anti Itch is a TOPICAL OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by L. Perrigo Company. 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: 00113-0471-64
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Hydrocortisone Topical

Product Information

NDC	00113-0471
Product ID	0113-0471_ecd6d841-40b9-42c9-825d-d172cd04824d
Associated GPIs	90550075004210
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	Good Sense Anti Itch
Proprietary Name Suffix	n/a
Non-Proprietary Name	hydrocortisone
Product Type	HUMAN OTC DRUG
Dosage Form	OINTMENT
Route	TOPICAL
Active Ingredient Strength	1
Active Ingredient Units	g/100g
Substance Name	HYDROCORTISONE
Labeler Name	L. Perrigo Company
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 00113-0471-64 (00113047164)

Pricing Information	N/A
NDC Package Code	0113-0471-64
Billing NDC	00113047164
Package	1 TUBE in 1 CARTON (0113-0471-64) / 28 g in 1 TUBE
Marketing Start Date	2021-01-23
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL ecd6d841-40b9-42c9-825d-d172cd04824d 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

•: for the treatment of diaper rash. Ask a doctor.
•: in the genital area if you have a vaginal discharge. Ask a doctor.

When using this product

•: avoid contact with the 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
•: rectal bleeding occurs
•: 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

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

•: for itching of skin irritation, inflammation, and rashes:
•: 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 and genital itching, adults:
•: 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: ask a doctor

Other information

•: store at 20°-25°C (68°-77°F)

Inactive ingredients

aloe barbadensis leaf juice, white petrolatum

Questions or comments?

1-800-719-9260

Principal Display Panel

Water Resistant Formula

Relieves Itch Fast

Skin Irritation & Rashes

Insect Bites & Poison Ivy

Inflammation & Redness

Psoriasis

Plus a Soothing Moisturizer

#1 Doctor Recommended anti-itch active ingredient

Lasts 10 Hours

Maximum Strength

Anti-Itch Ointment

Hydrocortisone 1% Anti-Itch Ointment

Compare to active ingredient of Cortizone 10®

100% SATISFACTION GUARANTEED

NET WT 1 OZ (28g)

INGREDIENTS AND APPEARANCE

GOOD SENSE ANTI ITCH

hydrocortisone ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0113-0471
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)
PETROLATUM (UNII: 4T6H12BN9U)

Product Characteristics
Color	WHITE (clear)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0113-0471-64	1 in 1 CARTON	01/23/2021
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	01/23/2021

Labeler - L. Perrigo Company (006013346)

Revised: 1/2021

Document Id: ecd6d841-40b9-42c9-825d-d172cd04824d

Set id: ecd6d841-40b9-42c9-825d-d172cd04824d

Version: 1

Effective Time: 20210126