HYDROCORTISONE - hydrocortisone lotion 
Physicians Total Care, 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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Active ingredient

Hydrocortisone 1%

Purpose  

Anti-itch

Uses

  • for temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:
  • eczema
  • psoriasis
  • poison ivy, oak, sumac
  • insect bites
  • detergents
  • jewelry
  • seborrheic dermatitis
  • soaps
  • external genital 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 the treatment of diaper rash. Ask a doctor.
  • for external genital itching if you have a vaginal discharge. Ask a doctor.

When using this product

  • avoid contact with the eyes
  • do not begin use of any other hydrocortisone product unless you have asked a doctor
  • for external anal itching do not exceed the recommended daily dosage unless directed by a doctor. In case of bleeding, consult a doctor promptly.
  • do not put this product 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

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. Ask a doctor.

for external anal itching:

  • adults: when practical, cleanse 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 application of this product.
  • children under 12 years of age with external anal itching: ask a doctor

Inactive ingredients  

cetyl alcohol, glyceryl monostearate SE, isopropyl palmitate, methylparaben, propylene glycol, propylparaben, purified water, sodium lauryl sulfate

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

Compare to Cortaid® active ingredient

Hydrocortisone Lotion 1%

Maximum Strength

Anti-Itch Lotion

Easy to use for Larger Areas


Hydrocortisone Lotion 1% Label


4 fl oz (118 mL

NDC 54868-1913-0


Hydrocortisone Lotion 1% Label



Distributed by:
Physicians Total Care, Inc.
Tulsa, OK    74146
HYDROCORTISONE 
hydrocortisone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-1913(NDC:45802-283)
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE1 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CETYL ALCOHOL 
ISOPROPYL PALMITATE 
METHYLPARABEN 
PROPYLENE GLYCOL 
PROPYLPARABEN 
WATER 
SODIUM LAURYL SULFATE 
Packaging
#Item CodePackage Description
1NDC:54868-1913-0118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/10/2013
Labeler - Physicians Total Care, Inc. (194123980)
Establishment
NameAddressID/FEIBusiness Operations
Physicians Total Care, Inc.194123980relabel(54868-1913)

Revised: 02/2013
Document Id: b9a5c065-6368-4df4-95bf-e73e0ec4cb97
Set id: 48ea5e37-99ab-4843-95dc-b7dd2f163124
Version: 2
Effective Time: 20130214
 
Physicians Total Care, Inc.