Hydrocortisone by Unifirst First Aid Corporation HYDROCORTISONE cream

Hydrocortisone by

Drug Labeling and Warnings

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

Hydrocortisone 1.0%

Purpose

Antipruritic (Anti itch)

Uses

• for the temporary relief of itching associated with minor skin irritations, inflamation 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 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 reccommeded daily dosage unless directed by a doctor

Stop use and ask a doctor if

• condition worsens
• symptoms persist for more than 7 days
• symptoms clear up and reappear again withih a few days
• 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: ask a doctor

For externalanal and genital itching in adults:

• when practical, clean the affected area with mild soap and warm water and rinse thoroughly
• gently dry by patting or blotting with toilet tissue or a soft cloth

Children under 12 years of age, ask a doctor

Other information

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

Inactive ingredient

emulsifying wax, ethyl alcohol, methylparaben, mineral oil, paraffin, petrolatum, propylparaben, purified water, white wax

Questions or comments?

1-800-869-6970

Green Guard Hydrocortisone Label

Pull up and tear off to dispense

Maximum Strength

Hydrocortisone
cream 1%

0.9 Gram 25 Single Dose Packets
Green Guard
Distributed by Green Guard®, St. Louis, Missouri 63045

INGREDIENTS AND APPEARANCE

HYDROCORTISONE 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 47682-397
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
ALCOHOL (UNII: 3K9958V90M)
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
PARAFFIN (UNII: I9O0E3H2ZE)
PETROLATUM (UNII: 4T6H12BN9U)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
WHITE WAX (UNII: 7G1J5DA97F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 47682-397-71	20 in 1 BOX	04/15/2013	07/01/2019
1		0.9 g in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 47682-397-12	10 in 1 BOX	04/15/2013	07/01/2019
2		0.9 g in 1 PACKET; Type 0: Not a Combination Product
3	NDC: 47682-397-73	25 in 1 BOX	06/06/2016
3	NDC: 47682-397-99	0.9 g in 1 PACKET; Type 0: Not a Combination Product
4	NDC: 47682-397-35	144 in 1 BAG	06/30/2017
4		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	04/15/2013

Labeler - Unifirst First Aid Corporation (832947092)