HYDRO SKIN- hydrocortisone lotion 
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.

----------

Amerisource Bergen Anti-Itch Lotion 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.
  • 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. Do not begin use of any other hydrocortisone product unless you have consulted a doctor.

Keep out of reach of children.

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

Directions

shake well before use

adults and children 2 years of age and older:

children under 2 years of age:

for external anal itching:

Inactive ingredients

benzyll alcohol, emulsifying wax, glycerin, isopropyl palmitate, lactic acid, purified water, sorbitol 70% solution

Questions or comments?

1-800-645-2158

Package/Label Principal Display Panel

Rugby Laboratories

Maximum Strength

Anti-Itch Lotion

hydrocortisone 1%

Hydro Skin 1% Lotion

HYDRO SKIN 
hydrocortisone lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-5105
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 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
LACTIC ACID (UNII: 33X04XA5AT)  
SORBITOL (UNII: 506T60A25R)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0536-5105-97 118 mL in 1 BOTTLE
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: b92989a1-d34d-46cf-bb22-1ac92bd209b5
Set id: bca3ff9b-bf2c-4a03-a1ff-bec084b0995b
Version: 1
Effective Time: 20130115
 
Rugby Laboratories