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Hydrocortisone by Safetec of America, Inc.

Medically reviewed on Dec 15, 2017

Dosage form: cream
Ingredients: Hydrocortisone 10mg in 1g
Labeler: Safetec of America, Inc.
NDC Code: 61010-5800

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.

Safetec First Aid 1% Hydrocortisone Cream

Drug Facts

Active ingredient

Hydrocortisone 1.0%

Purpose

Anti-itch

Uses:
  • 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 and 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
  • in eyes
  • for feminine itching
  • if condition worsens or lasts more than 7 days, or clears up and occurs again within a few days
  • with any other Hydrocortisone product unless you have consulted a doctor

KEEP OUT OF REACH OF CHILDREN.

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

Directions:
  • for adults and children 2 years of age and older: apply to affected area 3 to 4 times daily
  • 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 an appropriate cleansing pad
  • gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
  • children under 12 years of age: for external anal itching, consult a doctor

Other information:
  • store at room temperature (do not freeze)
  • do not use any opened or torn packets

Inactive ingredients:

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

Questions or Comments? 1-800-456-7077

Manufactured by
SAFETEC OF AMERICA, Inc.
Buffalo, NY 14215 . 800-456-7077
www.safetec.com

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL – 0.9g Pouch Label

Safetec

1% Hydrocortisone Cream™

0.9 g (1/32 oz.)

Safetec of America, Inc.

Buffalo, NY 14215

800-456-7077

PRINCIPAL DISPLAY PANEL – Box Label

NDC 61010-5800-2

Safetec

First Aid

1% Hydrocortisone Cream

For Temporary Relief of

Itching Associated with

Minor Skin Irritations,

Inflammation, or Rashes

Reorder no. 53110

To reorder:

Call: 1-800-456-7077

Fax: 716-895-2969

Online: www.safetec.com

HYDROCORTISONE 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61010-5800
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 
cetostearyl alcohol 
polysorbate 60 
PEG-150 distearate 
steareth-20 
Packaging
#Item CodePackage Description
1NDC:61010-5800-325 POUCH (25 POUCH) in 1 BOX
1NDC:61010-5800-10.9 g in 1 POUCH
2NDC:61010-5800-2144 POUCH (144 POUCH) in 1 BOX
2NDC:61010-5800-10.9 g in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/15/2010
Labeler - Safetec of America, Inc. (874965262)
Establishment
NameAddressID/FEIOperations
Safetec of America, Inc.874965262MANUFACTURE

 
Safetec of America, Inc.

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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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