REXALL ANTI ITCH MAXIMUM STRENGTH RELIEF- hydrocortisone cream 
Dolgencorp, LLC

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.

----------

Dolgencorp, LLC Anti-Itch Cream Drug Facts

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, 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.

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, avena sativa (oat) kernel extract, benzyl alcohol, butylated hydroxytoluene, cetostearyl alcohol, cetyl alcohol, chamomilla recutita (matricaria) flower extract, diazolidinyl urea, dimethicone, distearyldimonium chloride, edetate disodium, glycerin, glyceryl monostearate, hydrolyzed collagen, hydrolyzed elastin, hydrolyzed jojoba esters, jojoba esters, magnesium ascorbyl phosphate, menthyl lactate, methyl gluceth-20, methylparaben, petrolatum, polysorbate 60, potassium hydroxide, PPG-12/SMDI copolymer, propylparaben, purified water, retinyl palmitate, stearamidopropyl PG-dimonium chloride phosphate, steareth-2, steareth-21, stearyl alcohol, tocopheryl acetate

Principal Display Panel

For relief of

Dry, Itchy skin

Rashes

Insect bites

Eczema & Psoriasis

Inflammation, irritation & redness

MAXIMUM STRENGTH RELIEF

Anti-Itch Cream

Intensive Healing Formula

with Antioxidants, chamomile & aloe

24 Hour

Clinically Proven to Moisturize 24 Hours

1% HYDROCORTISONE

NET WT 1 0Z (28 g)

Dolgencorp, LLC Anti-Itch Cream
Dolgencorp, LLC Anti-Itch Cream
REXALL ANTI ITCH  MAXIMUM STRENGTH RELIEF
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:55910-225
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
OAT 
BENZYL ALCOHOL 
BUTYLATED HYDROXYTOLUENE 
CETOSTEARYL ALCOHOL 
CETYL ALCOHOL 
CHAMOMILE 
DIAZOLIDINYL UREA 
DIMETHICONE 
DISTEARYLDIMONIUM CHLORIDE 
EDETATE DISODIUM 
GLYCERIN 
GLYCERYL MONOSTEARATE 
HYDROLYZED JOJOBA ESTERS (ACID FORM) 
MAGNESIUM ASCORBYL PHOSPHATE 
MENTHYL LACTATE, (-)- 
METHYL GLUCETH-20 
METHYLPARABEN 
PETROLATUM 
POLYSORBATE 60 
POTASSIUM HYDROXIDE 
PROPYLPARABEN 
WATER 
VITAMIN A PALMITATE 
STEARETH-2 
STEARETH-21 
STEARYL ALCOHOL 
Product Characteristics
ColorWHITE (Off white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55910-225-641 in 1 CARTON
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/31/2010
Labeler - Dolgencorp, LLC (068331990)

Revised: 12/2013
Document Id: bc8a5d5a-bbfe-4cb3-abd8-d262d041ea76
Set id: 894cf9ab-693a-4210-96df-605947f51b63
Version: 2
Effective Time: 20131210
 
Dolgencorp, LLC