WELLY ITCH FIX- hydrocortisone anti itch cream cream 
Welly Health PBC

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 ingredient

Hydrocortisone 1.0%

Purpose

Anti-itch

Uses

For temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:

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, consult a doctor.
  • for external genital itching if you have a vaginal discharge, consult a doctor.

When using this product

  • avoid contact with eyes
  • do not begin the use of any other hydrocortisone product unless you have consulted a doctor.
  • for external genital, feminine and anal itching do not exceed the recommended daily dosage unless directed by a doctor. In case of bleeding, stop use, consult a doctor.
  • do not put this product into the rectum by using fingers or any mechanical device or applicator.

Stop use and ask a doctor if

  • If condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and do not begin use of any other hydrocortisone product unless directed by a doctor.

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 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.

For external anal itching:

  • adults: when practical cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with toilet tissue or a soft cloth before application of this product.
  • children under 12 years of age with external anal itching: consult a doctor.

Other information

store at controlled room temperature 68° - 77ºF (20°-25°C).

Inactive ingredients

Aloe barbadensis leaf extract, Benzyl alcohol, Ceteareth-20, Cetearyl alcohol, Cetyl palmitate, Glycerin, Isopropyl myristate, Isostearyl neopentanoate, Methylparaben, PEG-40 stearate, Propylene glycol, Purified water

Principal Display Panel – Can Label

Welly First Aid Itch Fix 

NDC 72663-155-50

Hydrocortisone 1% Anti-itch Cream

2 tubes -0.57 oz(16g)   Total Net Wt 1.14oz (32g)

Principal Display Panel – Can Label

Principal Display Panel – 0.57oz Tube Label

NDC 72663-155-50    Welly First Aid Itch fix

Hydrocortisone 1% Anti-itch Cream  Net Wt. 0.57 oz (16g)

Principal Display Panel – 0.57oz Tube Label

WELLY ITCH FIX 
hydrocortisone anti itch cream cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72663-155
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
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ALUMINUM SULFATE (UNII: 34S289N54E)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CALCIUM ACETATE (UNII: Y882YXF34X)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
ICODEXTRIN (UNII: 2NX48Z0A9G)  
GLYCERIN (UNII: PDC6A3C0OX)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72663-155-502 in 1 CAN02/22/2019
116 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/22/2019
Labeler - Welly Health PBC (116766884)
Registrant - Welly Health PBC (116766884)
Establishment
NameAddressID/FEIBusiness Operations
Sheffield Pharmaceuticals LLC151177797MANUFACTURE(72663-155)

Revised: 2/2019
Document Id: 0cf1abd1-278d-4f5c-99d3-252b41ff0aae
Set id: 0965a0ed-c8a2-4ce8-a873-287a60078d47
Version: 1
Effective Time: 20190223
 
Welly Health PBC