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Hydrocortisone Maximum Strength with Aloe

Medically reviewed on Feb 1, 2018

Dosage form: cream
Ingredients: HYDROCORTISONE 1g in 100g
Labeler: Proficient Rx LP
NDC Code: 63187-567

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.

Hydrocortisone Cream, USP 1% with Aloe

Active Ingredient

Hydrocortisone, USP 1%

Purpose

Anti-itch

Uses

For the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:

eczema
insect bites
poison ivy
poison oak
poison sumac
soaps
jewelry
detergents
cosmetics
psoriasis
seborrheic dermatitis
for external genital, feminine and anal itching
other uses of this product should be only under the advice and supervision of a doctor

Warnings

For external use only

Do not use
for external feminine itching if you have a vaginal discharge. Consult a doctor.
for the treatment of diaper rash. Consult a doctor.

When using this product
 
avoid contact with the eyes
 
do not begin the use of any other hydrocortisone product unless directed by a doctor
 
for external anal itching:
                o   do not use more than directed unless directed by a doctor   
                o   do not put this product into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if
symptoms last for more than 7 days
the condition gets worse
symptoms clear up and occur again in a few days
rectal bleeding occurs, consult doctor promptly

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 and older

apply to affected area not more than 3 to 4 times daily

Children under 2 years of age

do not use, consult a doctor

For external anal itching

Adults: when practical, clean the affected area with mild soap and warm water, rinse thoroughly, gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product

Children under 12 years of age: consult a doctor

Other Information
Store at room temperature 59°-86°F (15°-30°C).  Protect from freezing.
Before using any medication, read all label directions.  Keep carton, it contains important information.

Inactive Ingredients

aloe vera concentrate, cetyl alcohol, glyceryl stearate, isopropyl myristate, methylparaben, polyoxyl 40 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sorbic acid, sorbitan monostearate, stearyl alcohol, white wax.  May contain citric acid or sodium citrate solution to adjust pH.

Questions?

1-800-432-8534 between 9 am and 4 pm EST, Monday – Friday.

PRINCIPAL DISPLAY PANEL

MAJOR®
Maximum Strength

Relabeled by:

Proficient Rx LP

Thousand Oaks, CA 91320


NDC 63187-567-01
Hydrocortisone ‚óŹ 10
Hydrocortisone Cream, USP 1%
antipruritic (anti-itch) cream with Aloe
NET WT 1 OZ (28 g)
Compare to the Active ingredient in Cortizone • 10®*
Temporary Relief of Itching and Rashes Due to:

·         Insect Bites
·         Eczema
·         Soaps
·         Poison Ivy, Oak, Sumac
·         Seborrheic Dermatitis
·         Cosmetics
·         Psoriasis
·         Jewelry
·         Detergents

03390311B1             VC110479     Rev 06/11

Carton Image 1

Carton Image 2

HYDROCORTISONE MAXIMUM STRENGTH WITH ALOE 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63187-567(NDC:0904-7623)
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 
CETYL ALCOHOL 
CITRIC ACID MONOHYDRATE 
GLYCERYL MONOSTEARATE 
ISOPROPYL MYRISTATE 
METHYLPARABEN 
SORBITAN MONOSTEARATE 
STEARYL ALCOHOL 
WHITE WAX 
POLYOXYL 40 STEARATE 
POLYSORBATE 60 
PROPYLENE GLYCOL 
PROPYLPARABEN 
WATER 
SODIUM CITRATE 
SORBIC ACID 
Packaging
#Item CodePackage Description
1NDC:63187-567-011 TUBE in 1 CARTON
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/21/2009
Labeler - Proficient Rx LP (079196022)
Establishment
NameAddressID/FEIOperations
Proficient Rx LP079502574REPACK(63187-567), RELABEL(63187-567)

 
Proficient Rx LP

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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