HYDROCORTISONE- hydrocortisone cream 
Safetec of America, Inc.

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.

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Drug Facts

Active Ingredients

Hydrocortisone USP 1%

Purpose

Antipruritic (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 for external genital, feminine, and anal itching

Warnings

For external use only

If pregnant or breast-feeding, ask a health professional before use

Do not use

  • In the eyes
  • For diaper rash
  • For external genital or feminine itching if you have a vaginal discharge
  • More than the recommended daily dosage unless directed by a doctor
  • This product in the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

  • Condition worsens, symptoms persist for more than 7 days, or clear up and occur again within a few days. Do not begin use of any other hydrocortisone product unless you have asked a doctor
  • In case of bleeding when used for anal itching

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Directions

Other Information

Inactive Ingredients

Cetostearyl Alcohol, Glyceryl Monostearate SE, Methylchloroisothiazolinone, Propylene Glycol, Purified Water, Stearic Acid, Triethanolamine, White Soft Paraffin

Principal Display Panel - 1 oz. Tube Label

Safetec®

1% Hydrocortisone Cream

For Itching, Inflammation, and Rashes

Net Wt. 1oz. (28.4g)

Reorder No. 53111

Manufactured for: Safetec of America, Inc.
Buffalo, NY 14215 | 1-800-456-7077
Made In India KD/503

Principal Display Panel - 1 oz. Tube Label
HYDROCORTISONE 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61010-4402
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
hydrocortisone (UNII: WI4X0X7BPJ) (hydrocortisone - UNII:WI4X0X7BPJ) hydrocortisone10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TROLAMINE (UNII: 9O3K93S3TK)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61010-4402-128.4 g in 1 TUBE; Type 0: Not a Combination Product11/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/01/2019
Labeler - Safetec of America, Inc. (874965262)
Registrant - Safetec of America, Inc. (874965262)

Revised: 11/2019
Document Id: 03c53289-95c0-482e-8012-bffe3c5927a5
Set id: e304569e-575f-498c-bc65-c9336a0bd6ea
Version: 1
Effective Time: 20191101
 
Safetec of America, Inc.