HYDROSKIN- 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.

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Rugby HydroSKIN 1% Hydrocortizone Lotion 4 oz (7997)

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

benzyl alcohol, cetyl alcohol, glycerin, glyceryl monostearate, isopropyl palmitate, lactic acid, polysorbate 60, propylene glycol, purified water, sorbitan monostearate, sorbitol solution 70%, stearyl alcohol, white wax.

Questions or comments?

1-800-645-2158

Package/Label Principal Display Panel

Rugby Laboratories

Maximum Strength

HydroSKIN

hydrocortisone 1% Lotion

HydroSKIN 1% Lotion
HYDROSKIN 
hydrocortisone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1079
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
WHITE WAX (UNII: 7G1J5DA97F)  
LACTIC ACID, L- (UNII: F9S9FFU82N)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-1079-97118 mL in 1 BOTTLE; Type 0: Not a Combination Product08/25/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/25/2015
Labeler - Rugby Laboratories (079246066)

Revised: 12/2017
Document Id: 5f8d08bd-140b-5416-e053-2a91aa0a3a35
Set id: 5d96dccc-5117-4a47-b0af-f2a2c09a0c8f
Version: 5
Effective Time: 20171204
 
Rugby Laboratories