CAREONE ANTI ITCH- hydrocortisone cream 
Velocity Pharma LLC

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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Anti-Itch Cream

Active ingredient

Hydrocortisone 1%

Purpose

Anti-itch

Uses

Warnings

For external use only

Do not use

  • for the treatment of diaper rash. Ask a doctor.
  • in the genital area if you have a vaginal discharge. Ask a doctor.

When using this product

  • avoid contact with the eyes
  • do not use more than directed unless told to do so by a doctor
  • do not put directly into 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, and do not begin use of any other hydrocortisone product unless you have asked a doctor
  • rectal bleeding occurs

Keep out of reach of children.

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

Directions

Other information

Inactive ingredients

aloe barbadensis leaf juice, avena sativa (oat) kernel extract, benzyl alcohol, butylated hydroxytoluene, cetostearyl alcohol, cetyl alcohol, chamomilla recutita (matricaria) flower extract, diazolidinyl urea, dimethicone, distearyldimonium chloride, edetate disodium, glycerin, glyceryl monostearate, hydrolyzed collagen, hydrolyzed elastin, hydrolyzed jojoba esters, jojoba esters, magnesium ascorbyl phosphate, menthyl lactate, methyl gluceth-20, methylparaben, petrolatum, polysorbate 60, potassium hydroxide, PPG-12/SMDI copolymer, propylparaben, purified water, retinyl palmitate, stearamidopropyl PG-dimonium chloride phosphate, steareth-2, steareth-21, stearyl alcohol, tocopheryl acetate

Questions or comments?

Keep Carton for complete information i.e. Help line number and company address

Principal Display Panel

Careone Anti Itch_Shipper Label

CAREONE ANTI ITCH 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72351-006
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
OAT (UNII: Z6J799EAJK)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CHAMOMILE (UNII: FGL3685T2X)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)  
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PETROLATUM (UNII: 4T6H12BN9U)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
STEARETH-2 (UNII: V56DFE46J5)  
STEARETH-21 (UNII: 53J3F32P58)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
Product Characteristics
Colorwhite (Off white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72351-006-0081 in 1 BOX06/11/2018
156.7 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 finalpart34806/11/2018
Labeler - Velocity Pharma LLC (876894019)

Revised: 6/2018
Document Id: 6eb0315e-1674-d195-e053-2a91aa0addf9
Set id: 44365b27-a75d-49e5-8c08-73cbacca21b5
Version: 2
Effective Time: 20180615
 
Velocity Pharma LLC