ITCH RELIEF- hydrocortisone 1% cream 
Trifecta Pharmaceuticals USA 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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CVS Health Itch Relief Cream

Drug Facts

Active Ingredient

Hydrocortisone 1%

Purpose

Anti-itch

Keep out of Reach of Children

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

Uses

For temporary relief of itching associated with minor skin irritataions, 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

When using this Product

Stop Using this product and ask a doctor if

Directions

For itching or skin irritations, inflammation, and rashes.

Adults and children 2 years and older

Children under 2 years of age

For External and Anal Itching

Other Information

Store at controlled room temperature 20°-25°C (68°-77°F)

Inactive Ingredients

Aloe Barbadensis leaf juice, cetyl alcohol, Dimethicone, EDTA, Ethylparaben, Ginger Oil, Glycerin, Glyceryl stearate, Maltodextrin, Methyl gluceth-20, Methylparaben, Methylpentadecane, petrolatum, 2- Phenoxyethyl alcohol, Polysorbate 80, Propylene glycol, purified water, Stearic acid, Trisodium citrate dihydrate, Vitamin E.

Questions

Call 1-800- SHOP CVS

Other Information

This product is not manufactured or distributed by Chattem Inc. distributor of Cortizone -10®

Distributed By:

CVS Pharmacy, Inc.

One CVS Drive,

Woonsocket, RI. 02895

Product of China V-36756

Packaging

CVS 340113 Hydrocortisone cream

ITCH RELIEF 
hydrocortisone 1% cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-057
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
3-METHYLPENTADECANE (UNII: X64R3JC095)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PETROLATUM (UNII: 4T6H12BN9U)  
WATER (UNII: 059QF0KO0R)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
GLYCERIN (UNII: PDC6A3C0OX)  
GINGER OIL (UNII: SAS9Z1SVUK)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
EDETIC ACID (UNII: 9G34HU7RV0)  
METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
ETHYLPARABEN (UNII: 14255EXE39)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69396-057-011 in 1 BOX09/17/2020
128 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 finalpart34809/15/2020
Labeler - Trifecta Pharmaceuticals USA LLC (079424163)

Revised: 1/2023
Document Id: f276f813-a269-42ad-e053-2a95a90a70fd
Set id: af5daf6c-bcad-8ebf-e053-2a95a90af1b0
Version: 2
Effective Time: 20230117
 
Trifecta Pharmaceuticals USA LLC