MEDI-FIRST PLUS HYDROCORTISONE 1%- hydrocortisone acetate 1% cream MEDI-FIRST HYDROCORTISONE 1%- hydrocortisone acetate 1% cream

Medi-First Plus Hydrocortisone 1% by

Drug Labeling and Warnings

Medi-First Plus Hydrocortisone 1% by is a Otc medication manufactured, distributed, or labeled by Unifirst First Aid Corporation, Medique Products, Prestige Packaging. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient

Hydrocortisone Acetate 1%

PURPOSE

Purpose

Anti-itch

INDICATIONS & USAGE

Uses

• for the temporary relief of itching associated with minor skin irritations and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, 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

Do not use

• for the treatment of diaper rash
• in eyes
• for feminine itching

STOP USE

Stop use and ask a doctor if

• condition worsens or lasts more than 7 days, or clears up and occurs again within a few days
• you begin use of any 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 the 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 appropriate cleansing pad
• gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product

OTHER SAFETY INFORMATION

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, glyceryl fatty acid ester, mineral oil,
petrolatum, phenoxyethanol, water

QUESTIONS

Questions or comments? 1-800-634-7680

PRINCIPAL DISPLAY PANEL

Medi-First®

1% Hydrocorisone Cream

Temporary relief of itching associated with minor skin irritation, inflamation and rashes

Item #21173

Net Wt. 0.9 g (1/32 oz) Packets/ 25 per box

Made in China

PRINCIPAL DISPLAY PANEL

Medi-First® Plus

Hydrocortisone Cream 1%

Temporary relief of itching associated with minor skin irritation, inflamation and rashes

25 Units / Net Wt 0.9 g (1/32 oz)

Item #93373

Made in China

INGREDIENTS AND APPEARANCE

MEDI-FIRST PLUS HYDROCORTISONE 1% 
hydrocortisone acetate 1% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 47682-981
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE ACETATE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
WATER (UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 47682-981-73	25 in 1 PACKET	04/01/2023
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	04/01/2023

MEDI-FIRST HYDROCORTISONE 1% 
hydrocortisone acetate 1% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 47682-980
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE ACETATE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
WATER (UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 47682-980-35	144 in 1 BOX	04/01/2023
1		0.9 g in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 47682-980-73	25 in 1 PACKET	04/01/2023
2	NDC: 47682-980-99	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	04/01/2023

Labeler - Unifirst First Aid Corporation (832947092)

Establishment
Name	Address	ID/FEI	Business Operations
Prestige Packaging		080667761	pack(47682-980, 47682-981)

Establishment
Name	Address	ID/FEI	Business Operations
Medique Products		086911794	pack(47682-980, 47682-981)