Label: UNISHIELD 1%- hydrocortisone cream
- NDC Code(s): 49314-0005-1
- Packager: Unishield
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 15, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
-
INDICATIONS & USAGE
Uses
- for temorary relief of itching associated with minor skin irritations, inflammation and rashes due to eczema, insect bites, posison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis and scrapes
- other uses of this product should be only under the advice and supervision of a doctor
-
WARNINGS
Warnings
For external use only.
Do not use
- for the treatment of diaper rash
- in eyes
- for feminine itching
When using this product:
- Keep out of eyes, ears, and mouth
- In case of contact with eyes, rinse eyes throughly with water
Stop use and ask a doctor if
condition worsens or lasts more than 7 days, or clears and occurs again within a few days
you begin use of other hydrocortisone product unless you have consulted a doctor
bleeding occurs
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Directions
- For adults and children 2 years of age and older: apply to affected area 3 to 4 times daily
- children under 12 years of age: for external anal itching, consult a doctor
- children under 2 years of age: do not use, consult a doctor
- adults for external anal itching when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with an appropriate cleansing pad
- gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
UNISHIELD 1%
hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49314-0005 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 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) MINERAL OIL (UNII: T5L8T28FGP) PETROLATUM (UNII: 4T6H12BN9U) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49314-0005-1 25 in 1 BOX 11/15/2023 1 0.9 g in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M017 11/15/2023 Labeler - Unishield (790677053) Establishment Name Address ID/FEI Business Operations Nantong Health & Beyond Hygienic Products Inc. 421280161 manufacture(49314-0005)