Label: HYDROSKIN- hydrocortisone lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 0536-1079-97 - Packager: Rugby Laboratories
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated December 4, 2017
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- Active ingredient
- Purpose
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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
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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
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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
- Questions or comments?
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INGREDIENTS AND APPEARANCE
HYDROSKIN
hydrocortisone lotionProduct 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)
