ITCH RELIEF- hydrocortisone 1% cream

Itch Relief by

Drug Labeling and Warnings

Itch Relief by is a Otc medication manufactured, distributed, or labeled by Trifecta Pharmaceuticals USA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• Eczema
• Insect bites
• poison ivy
• poison oak
• poison sumac
• soaps
• detergents
• cosmetics
• jewelry
• seborrheic dermatitis
• psoriasis
• sunburn
• temporarily relieves external anal and genital itching.

Other uses of this product should be only under the advice and supervision of a doctor

Warnings

For External Use Only

Do not use

• In the genital area if you have a vaginal discharge.

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 rectum by using fingers or any mechanical device or applicator.

Stop Using this product and ask a doctor if

• Conditions worsen
• 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.

Directions

For itching or skin irritations, inflammation, and rashes.

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

• ask a doctor.

For External and Anal Itching

• Adults: When practical, clean the affected area with mild soap and warm water and rinse thoroughly
• gently dry by patting or blotting with toilet tissue or a soft cloth before applying
• apply to affected area not more than 3 to 4 times daily
• Children under 12 years of age: ask a doctor

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

INGREDIENTS AND APPEARANCE

ITCH RELIEF 
hydrocortisone 1% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69396-057
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69396-057-01	1 in 1 BOX	09/17/2020
1		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	09/15/2020

Labeler - Trifecta Pharmaceuticals USA LLC (079424163)