ANTI-ITCH CREAM- hydrocortisone cream cream

Anti-itch cream by

Drug Labeling and Warnings

Anti-itch cream by is a Otc medication manufactured, distributed, or labeled by Shares inc, Shares Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

• eczema
• insect bites
• poison ivy, oak, or sumac
• soaps, detergents, or cosmetics
• jewelry

Warnings

for external use only

Do not use

• with any other hydrocortisone product unless you have consulted a doctor
• for the treatment of diaper rash, consult a doctor

When using this product

avoid contact with eyes

Stop use and ask a doctor if

• condition worsens
• symptoms persist for more than 7 days
• symptoms clear up and occur again within a few days

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

• do not use if package is torn, cut or opened
• store at room tempreature (do not freeze)
• see packet for Lot Number and expiration date

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

PRINCIPAL DISPLAY PANEL

Hydrocortisone

1% hydrocortisone anti-itch cream

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

20 pkts per box

INGREDIENTS AND APPEARANCE

ANTI-ITCH CREAM 
hydrocortisone cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82940-220(NDC:42961-220)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE ACETATE	0.01 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82940-220-01	20 in 1 BOX	08/19/2022
1		0.9 g in 1 PACKET; 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	08/19/2022

Labeler - Shares inc (081533663)

Establishment
Name	Address	ID/FEI	Business Operations
Shares Inc		081533663	repack(82940-220)