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NDC 00363-0670-04 Intensive Healing Eczema 1.02 g/100g Details

Intensive Healing Eczema 1.02 g/100g

Intensive Healing Eczema is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by Walgreens. 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: 00363-0670-04
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Hydrocortisone Topical

Product Information

NDC	00363-0670
Product ID	0363-0670_477234df-ba16-4e97-a96e-219034074af3
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	Intensive Healing Eczema
Proprietary Name Suffix	n/a
Non-Proprietary Name	Hydrocortisone
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	1.02
Active Ingredient Units	g/100g
Substance Name	HYDROCORTISONE
Labeler Name	Walgreens
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 00363-0670-04 (00363067004)

Pricing Information	N/A
NDC Package Code	0363-0670-04
Billing NDC	00363067004
Package	99.2 g in 1 TUBE (0363-0670-04)
Marketing Start Date	2018-03-25
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 3d27f041-c554-4139-87b5-709537785f22 Details

Active Ingredient

Hydrocortisone 1%

Purpose

Anti-Itch

Uses

Temporarily relieves the itching and discomfort associated with minor skin irritations, rashes and inflammation due to excema.

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

Warnings

For external use only.

Do not use

Do not use for the treatment of diaper rash. Consult 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.

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.

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 or older: apply to affected area not more than 3 to 4 times daily.

children under 2 years of age: ask a doctor.

Inactive Ingredients

glycerin, methylparaben, propylparaben, petrolatum, cetearyl alcohol, cetyl palmitate, isostearyl neopentanoate, isopropyl myristate, PEG-40 stearate, ceteareth 20, benzyl alcohol, aloe, dimethicone, vitamin A, vitamin D, vitamin E, chamomile extract, sodium citrate, magnesium ascorbyl phosphate (vitamin C), shea butter, EDTA, water

Directions

Apply to affected area not more than 3 to 4 times daily.

Label

INGREDIENTS AND APPEARANCE

INTENSIVE HEALING ECZEMA

hydrocortisone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-0670
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	1.02 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)	64.89 g in 100 g
GLYCERIN (UNII: PDC6A3C0OX)	15 g in 100 g
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)	5 g in 100 g
CETYL PALMITATE (UNII: 5ZA2S6B08X)	3 g in 100 g
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)	3 g in 100 g
PETROLATUM (UNII: 4T6H12BN9U)	2 g in 100 g
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)	1.5 g in 100 g
ALOE VERA LEAF (UNII: ZY81Z83H0X)	1.0 g in 100 g
BENZYL ALCOHOL (UNII: LKG8494WBH)	1.0 g in 100 g
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)	.5 g in 100 g
PEG-40 STEARATE (UNII: ECU18C66Q7)	.5 g in 100 g
EDETATE DISODIUM (UNII: 7FLD91C86K)	.5 g in 100 g
SHEA BUTTER (UNII: K49155WL9Y)	.5 g in 100 g
METHYLPARABEN (UNII: A2I8C7HI9T)	.2 g in 100 g
PROPYLPARABEN (UNII: Z8IX2SC1OH)	.1 g in 100 g
CHAMOMILE (UNII: FGL3685T2X)	.1 g in 100 g
SODIUM CITRATE (UNII: 1Q73Q2JULR)	.1 g in 100 g
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)	.02 g in 100 g
CHOLECALCIFEROL (UNII: 1C6V77QF41)	.02 g in 100 g
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)	.02 g in 100 g
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)	.02 g in 100 g
DIMETHICONE (UNII: 92RU3N3Y1O)	.01 g in 100 g

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0363-0670-04	99.2 g in 1 TUBE; Type 0: Not a Combination Product	03/25/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	03/25/2018

Labeler - Walgreens (008965063)

Name	Address	ID/FEI	Business Operations
Establishment
Unipack, Inc.		009248480	manufacture(0363-0670)

Revised: 2/2018

Document Id: 477234df-ba16-4e97-a96e-219034074af3

Set id: 3d27f041-c554-4139-87b5-709537785f22

Version: 1

Effective Time: 20180204

Search by Drug Name or NDC

NDC 00363-0670-04 Intensive Healing Eczema 1.02 g/100g Details

Intensive Healing Eczema 1.02 g/100g

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 00363-0670-04 (00363067004)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 3d27f041-c554-4139-87b5-709537785f22 Details

Active Ingredient

Purpose

Uses

Warnings

Do not use

When using this product

Stop use and ask a doctor if

Keep out of reach of children.

Directions

Inactive Ingredients

Directions

Label

INGREDIENTS AND APPEARANCE

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