Walgreen Co. Anti-Itch Drug Facts

Drug Labeling and Warnings

Drug Details [pdf]

ANTI ITCH- hydrocortisone lotion 
Walgreen Company

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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Walgreen Co. Anti-Itch Drug Facts

Active ingredient

Hydrocortisone 1%

Purpose

Anti-itch

Uses

• temporarily relieves itching associated with minor skin irritations, rashes, and inflammation due to eczema
• other uses of this product should be only under the advice and supervision of a doctor

Warnings

For external use only

Do not use

• for the treatment of diaper rash. Consult a doctor.

When using this product

• avoid contact with eyes
• do not use more than directed unless told to do so by a doctor

Stop use and ask a doctor if

• condition worsens, or if 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

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

• adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
• children under 2 years of age: ask a doctor

Other information

• store at 20-25°C (68-77°F)
• contents filled by weight, not volume

Inactive ingredients

aloe barbadensis leaf juice, avena sativa (oat) kernel extract, bisabolol, boswellia serrata gum, butyrospermum parkii (shea butter) extract, cetyl alcohol, dextrin, dimethicone, dipropylene glycol, edetate disodium, glycerin, glyceryl stearate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, isohexadecane, magnesium ascorbyl phosphate, maltodextrin, methyl gluceth-20, methylparaben, petrolatum, phenoxyethanol, polysorbate 60, propylparaben, purified water, retinyl palmitate, sodium citrate, tocopheryl acetate, zingiber officinale (ginger) root extract

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

INTENSIVE HEALING LOTION – MAXIMUM STRENGTH

Anti-Itch

1% Hydrocortisone

Anti-Itch Lotion

7 intensive moisturizers

Botanicals & antioxidant Vitamins A, C & E

Temporarily relieves eczema & itchy, dry skin

A+C+E

VITAMINS

Compare to Cortizone●10® Intensive Healing Lotion active ingredient

ANTI ITCH 
hydrocortisone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-0878
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
ALOE VERA LEAF (UNII: ZY81Z83H0X)
OAT (UNII: Z6J799EAJK)
LEVOMENOL (UNII: 24WE03BX2T)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
CETYL ALCOHOL (UNII: 936JST6JCN)
ICODEXTRIN (UNII: 2NX48Z0A9G)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ISOHEXADECANE (UNII: 918X1OUF1E)
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
METHYL GLUCETH-20 (UNII: J3QD0LD11P)
METHYLPARABEN (UNII: A2I8C7HI9T)
PETROLATUM (UNII: 4T6H12BN9U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
GINGER (UNII: C5529G5JPQ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-0878-25	1 in 1 CARTON	03/27/2012	05/11/2018
1		99 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	03/27/2012	05/11/2018

Labeler - Walgreen Company (008965063)

Revised: 7/2019

Document Id: f8133490-44f3-437a-8ff3-7254009aeb04

34390-5

Set id: 27b0ac5e-ada2-4f85-995a-862f0a481ffb

Version: 2

Effective Time: 20190719