INTENSIVE HEALING ECZEMA- hydrocortisone lotion

Intensive Healing Eczema by

Drug Labeling and Warnings

Intensive Healing Eczema by is a Otc medication manufactured, distributed, or labeled by Walgreens, Unipack, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

Inactive Ingredients
Ingredient Name	Strength
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

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

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

Labeler - Walgreens (008965063)

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