INTENSIVE HEALING ECZEMA- hydrocortisone lotion 
Walgreens

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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

LabelLabelLabelLabel

INTENSIVE HEALING ECZEMA 
hydrocortisone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0670
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1.02 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-0670-0499.2 g in 1 TUBE; Type 0: Not a Combination Product03/25/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/25/2018
Labeler - Walgreens (008965063)
Establishment
NameAddressID/FEIBusiness Operations
Unipack, Inc.009248480manufacture(0363-0670)

Revised: 2/2018
Document Id: 477234df-ba16-4e97-a96e-219034074af3
Set id: 3d27f041-c554-4139-87b5-709537785f22
Version: 1
Effective Time: 20180204
 
Walgreens