UNISHIELD 1%- hydrocortisone cream

Unishield 1% by

Drug Labeling and Warnings

Unishield 1% by is a Otc medication manufactured, distributed, or labeled by Unishield, Nantong Health & Beyond Hygienic Products Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient

Hydrocortisone 1%

PURPOSE

Purpose  Anti-itch

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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

Other information

• Store at room temperature (do not freeze)
• Tamper evident, do not use any opened or torn packets

INACTIVE INGREDIENT

Inactive ingredients

cetearyl alcohol, ceteareth-20, ethylhexylglycerin, glycerin, glycerol fatty acid ester, mineral oil, petrolactum, phenoxyethanol, water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

UNISHIELD 1% 
hydrocortisone cream

Product 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)