HYDROSKIN- hydrocortisone cream 
Rugby Laboratories

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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Rite Aid Anti-Itch Cream Drug Facts

Active ingredient

Hydrocortisone 1%

Purpose

Anti-itch

Uses

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
  • for external anal itching, do not use more than directed. In case of bleeding, consult a doctor promptly 
  • do not insert cream 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

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

emulsifying wax, glycerin, isopropyl palmitate, lactic acid, purified water, sorbitol solution, Preservative: benzyl alcohol

Questions or comments?

1-800-645-2158

Principal Display Panel

Maximum Strength

Anti-Itch Cream

1% Hydrocortisone Anti-Itch Cream

HydroSkin 1% Cream

HYDROSKIN 
hydrocortisone cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-5108
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE 1 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
LACTIC ACID (UNII: 33X04XA5AT)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
Color WHITE (Off white) Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0536-5108-95 1 in 1 CARTON
1 28 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part348 10/29/2012
Labeler - Rugby Laboratories (191427277)

Revised: 1/2013
Document Id: 3143369a-e265-4bf0-86c4-5e2b43f75b85
Set id: f1e4ee6a-d58a-4c23-b389-d477acb60911
Version: 1
Effective Time: 20130115
 
Rugby Laboratories