HYDROSKIN- hydrocortisone lotion

HydroSKIN by

Drug Labeling and Warnings

HydroSKIN by is a Otc medication manufactured, distributed, or labeled by Rugby Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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
• cosmetics
• 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:

• 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

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

INGREDIENTS AND APPEARANCE

HYDROSKIN 
hydrocortisone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-1079
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-1079-97	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/25/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	08/25/2015

Labeler - Rugby Laboratories (079246066)