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

Medi-First 1% Hydrocortisone by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient

Hydrocortisone acetate (equivalent to Hydrocorisone 1%)

PURPOSE

Purpose

Anti-itch cream

INDICATIONS & USAGE

Uses

• for the temporary relief of itching associated with minor skin irritations and rashes
• 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. Consult a doctor.

WHEN USING

When using this product

• avoid contact with eyes
• do not begin use of any other hydrocortisone product unless you've consulted a doctor

STOP USE

Stop use and ask a doctor if

• condition worsens
• symptoms persist for more than 7 days
• condition clears up and occurs again within a few days

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

• adults and children 2 years of age and older: apply to the affected area not more than 3 to 4 times daily
• children under 2 years of age: do not use, consult a doctor

OTHER SAFETY INFORMATION

Other information

• clean the affected area
• store at room temperature (do not freeze)
• tamper evident. Do not use any opened or torn packets
• you may reportr a serioud adverse reaction to this product to 800-634-7680

INACTIVE INGREDIENT

Inactive ingredients

cetyl alcohol, citric acid, diazolidinyl urea, edetate disodium, glycerin, glyceryl monostearate, methylparaben, mineral oil, polyethylene glycol, propylene glycol, propylparaben, stearic acid, trolamine, water

QUESTIONS

Questions or comments? 1-800-634-7680

PRINCIPAL DISPLAY PANEL

Medi-First®

1% Hydrocortisone Cream

Temporary relief of itching associated with minor skin irritation and rashes

Item #21173

0.9 g (1/32 oz)

Packets - 25 per box

PRINCIPAL DISPLAY PANEL

Medi-First® Plus

Hydrocortisone Cream 1%

Temporary relief of itching associated with minor skin irritations and rashes

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

INGREDIENTS AND APPEARANCE

MEDI-FIRST HYDROCORTISONE 1% 
hydrocortisone acetate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 47682-207
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
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
STEARIC ACID (UNII: 4ELV7Z65AP)
TROLAMINE (UNII: 9O3K93S3TK)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
WATER (UNII: 059QF0KO0R)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
MINERAL OIL (UNII: T5L8T28FGP)
CETYL ALCOHOL (UNII: 936JST6JCN)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 47682-207-12	10 in 1 BOX	06/01/2021	04/30/2028
1		0.9 g in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 47682-207-35	144 in 1 BOX	06/01/2021	04/30/2028
2		0.9 g in 1 PACKET; Type 0: Not a Combination Product
3	NDC: 47682-207-73	25 in 1 BOX	06/01/2021	04/30/2028
3		0.9 g in 1 PACKET; Type 0: Not a Combination Product
4	NDC: 47682-207-99	0.9 g in 1 PACKET; Type 0: Not a Combination Product	06/01/2021	04/30/2028

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	06/01/2021	04/30/2028

MEDI-FIRST 1% HYDROCORTISONE 
hydrocortisone acetate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 47682-923
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
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
WATER (UNII: 059QF0KO0R)
CETYL ALCOHOL (UNII: 936JST6JCN)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
STEARIC ACID (UNII: 4ELV7Z65AP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
MINERAL OIL (UNII: T5L8T28FGP)
TROLAMINE (UNII: 9O3K93S3TK)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 47682-923-73	25 in 1 BOX	06/01/2021	04/30/2028
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	06/01/2021	04/30/2028

Labeler - Unifirst First Aid Corporation (832947092)