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.

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Amerisource Bergen Anti-Itch Lotion Drug Facts

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. 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:

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

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-5105
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
SORBITOL (UNII: 506T60A25R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-5105-97118 mL in 1 BOTTLE; Type 0: Not a Combination Product10/29/201211/30/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/29/201211/30/2018
Labeler - Rugby Laboratories (079246066)

Revised: 9/2019
 
Rugby Laboratories