Hydrocortisone Cream Maximum Strength - Select Brand

Drug Labeling and Warnings

Drug Details [pdf]

HYDROCORTISONE MAXIMUM STRENGTH- hydrocortisone cream 
L&R Distributors, Inc.

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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Hydrocortisone Cream Maximum Strength - Select Brand

Drug Facts

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:   do not use more than directed unless directed by a doctor   
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

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

NDC: 15127-140-01
Select Brand® 
the lower price name brand
MAXIMUM STRENGTH
Hydrocortisone Cream, USP 1%
Anti-Itch Cream
Itch and Rash Relief
Compare to the active ingredient of Cortaid® Maximum Strength Cream* 

NET WT 1 OZ (28g)

Hydrocortisone Cream
HYDROCORTISONE  MAXIMUM STRENGTH
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 15127-140
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SORBIC ACID (UNII: X045WJ989B)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
WHITE WAX (UNII: 7G1J5DA97F)  
Other Ingredients
Ingredient KindIngredient NameQuantity
May containCITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
May containSODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 15127-140-011 in 1 CARTON02/01/200601/31/2019
128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34802/01/200601/31/2019
Labeler - L&R Distributors, Inc. (012578514)
Registrant - Teva Pharmaceuticals USA, Inc. (001627975)

Revised: 7/2019
 
L&R Distributors, Inc.