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Hydrocortisone by Unifirst First Aid Corporation

Medically reviewed on June 30, 2017

Dosage form: cream
Ingredients: HYDROCORTISONE 10mg in 1g
Labeler: Unifirst First Aid Corporation
NDC Code: 47682-397

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Green Guard Maximum Strength Hydrocortisone Cream 1%

Drug Facts

Active ingredient

Hydrocortisone 1.0%

Purpose

Antipruritic (Anti itch)

Uses
  • for external genital, feminine and anal itching
  • for the temporary relief of itching associated with minor skin irritations, inflammation and rashes due to eczema, insect bites,
    poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, scrapes
  • 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

Stop use and ask a doctor if
  • bleeding occurs

Ask a doctor before use
  • if you have a vaginal discharge (for feminine itching)
  • for external itching, do not exceed the recommended daily dosage or if condition worsens or if symptoms persist for more than
    7 days or clear up and occur again within a few days

Keep out of reach of children.

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

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, consult a doctor

  • adults for external anal itching when practical, clean, clean 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
  • external itching for children under 12 years of age, 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

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

PRINCIPAL DISPLAY PANEL – 25 unit Box

Maximum Strength

Hydrocortisone
cream 1%

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

HYDROCORTISONE 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-397
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
METHYLPARABEN 
MINERAL OIL 
PARAFFIN 
PETROLATUM 
PROPYLPARABEN 
WATER 
WHITE WAX 
Packaging
#Item CodePackage Description
1NDC:47682-397-7120 PACKET in 1 BOX
10.9 g in 1 PACKET
2NDC:47682-397-1210 PACKET in 1 BOX
20.9 g in 1 PACKET
3NDC:47682-397-7325 PACKET in 1 BOX, UNIT-DOSE
3NDC:47682-397-990.9 g in 1 PACKET
4NDC:47682-397-35144 PACKET in 1 BAG
40.9 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/15/2013
Labeler - Unifirst First Aid Corporation (832947092)
Registrant - Safetec of America, Inc. (874965262)
Establishment
NameAddressID/FEIOperations
Safetec of America, Inc.874965262manufacture(47682-397)

 
Unifirst First Aid Corporation

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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