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

Medi-First Hydrocortisone by

Drug Labeling and Warnings

Medi-First Hydrocortisone by is a Otc medication manufactured, distributed, or labeled by Unifirst First Aid Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Hydrocortisone 1.0%

Purpose

Antipruritic (ant-itch)

Uses

• for the temporary relief of itching associated with minor skin irritations, inflammation and rashes
• for external genital, feminine, 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
• with any other Hydrocortisone product unless you have consulted a doctor
• if you have a vaginal discharge, consult a doctor

When using this product

• avoid contact with eyes
• do not put this product into rectum by using fingers, mechanical device or applicator
• do not exceed recommended daily dosage unless directed by a doctor

Stop use and ask a doctor if

• condition worsens, symptoms persist for more than 7 days or symptoms clear up and reappear again within a few days and do not begin use of any other hydrocortisone product
• rectal bleeding occurs

KEEP OUT OF REACH OF CHILDREN.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

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: do not use and ask a doctor

For external anal and genital itching in adults:

• when practical, clean 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 applying

Children under 12 years of age: ask a doctor

Other information

• store at room temperature 59° to 86° F (15° to 30° C)
• tamper evident, do not use if packet is torn, cut or opened
• avoid excessive heat and humidity

Inactive ingredients

benzoic acid, chlorphenesin, citric acid, glycerin, glyceryl monostearate, methylparaben, mineral oil, petrolatum, phenoxyethanol, polysorbate 80, purified water, titanium dioxide, trisodium citrate

Questions or comments?

1-800-634-7680

Medi-First 1% Hydrocortisone Cream Label

Medi-First®

1% Hydrocortisone Cream

Temporary relief of itching associated with minor skin irritation and rashes

0.9g (1/32oz) Packets

25 per box

Medi-First Plus 1% Hydrocortisone Cream Label

Medi-First® Plus

Hydrocortisone Cream 1%

Temporary relief of itching associated with minor skin irritation and rashes

25 Units of 0.9g (1/32oz) Packets

INGREDIENTS AND APPEARANCE

MEDI-FIRST PLUS HYDROCORTISONE 
1 % hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 47682-633
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)
WATER (UNII: 059QF0KO0R)
MINERAL OIL (UNII: T5L8T28FGP)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CHLORPHENESIN (UNII: I670DAL4SZ)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
BENZOIC ACID (UNII: 8SKN0B0MIM)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 47682-633-73	25 in 1 BOX	01/01/2020
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 not final	part348	01/01/2020

MEDI-FIRST HYDROCORTISONE 
1 % hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 47682-611
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)
WATER (UNII: 059QF0KO0R)
MINERAL OIL (UNII: T5L8T28FGP)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CHLORPHENESIN (UNII: I670DAL4SZ)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
BENZOIC ACID (UNII: 8SKN0B0MIM)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 47682-611-35	144 in 1 BAG	01/01/2020
1		0.9 g in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 47682-611-73	25 in 1 BOX	01/01/2020
2		0.9 g in 1 PACKET; Type 0: Not a Combination Product
3	NDC: 47682-611-12	10 in 1 BOX	01/01/2020
3		0.9 g in 1 PACKET; Type 0: Not a Combination Product
4	NDC: 47682-611-99	0.9 g in 1 PACKET; Type 0: Not a Combination Product	01/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/01/2020

Labeler - Unifirst First Aid Corporation (832947092)