ANTI-ITCH CREAM- hydrocortisone cream cream 
Shares 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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Hydrocortisone Cream

Active ingredients (in each packet)

Hydrocortisone acetate 1%

Purpose

anti-itch cream

Uses

temporarily relieves itching associated with minor skin irritations and rashes due to:

Warnings

for external use only

Do not use

When using this product

avoid contact with eyes

Stop use and ask a doctor if

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 over - apply to affected area not more than 3 to 4 times daily

children under 2 years - do not use

Other information

Inactive ingredients

cetyl alcohol, citric acid, diazolidinyl urea, edetate disodium, glycerin, glyceryl monostearate, methylparaben, mineral oil, polyethylene glycol, propylene glycol, propylparaben, purified water, stearic acid, trolamine

Questions

1-877-973-2811 Monday - Friday 8:00 AM to 5:00 PM

Hydrocortisone

1% hydrocortisone anti-itch cream

Net wt per pkt 1/32 oz (0.9 g)

20 pkts per box

Front Panel

ANTI-ITCH CREAM 
hydrocortisone cream cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82940-220(NDC:42961-220)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE0.01 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
WATER (UNII: 059QF0KO0R)  
TROLAMINE (UNII: 9O3K93S3TK)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
MINERAL OIL (UNII: T5L8T28FGP)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82940-220-0120 in 1 BOX08/19/2022
10.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/19/2022
Labeler - Shares inc (081533663)
Establishment
NameAddressID/FEIBusiness Operations
Shares Inc081533663repack(82940-220)

Revised: 8/2022
Document Id: e6a0968f-5342-f7e1-e053-2995a90ae952
Set id: e6a0968f-5341-f7e1-e053-2995a90ae952
Version: 1
Effective Time: 20220819
 
Shares inc