ANTI ITCH- hydrocortisone cream

Anti itch by

Drug Labeling and Warnings

Anti itch by is a Otc medication manufactured, distributed, or labeled by Weeks & Leo Co., Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Hydrocortisone 1 %

Uses

for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:

eczema

seborrheic dermatitis

psoriasis

insect bites

poison ivy, poison oak, and poison sumac

cosmetics

jewelry

detergents

soaps

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

When using this product

do not get into the eyes

Do not use

for the treatment of diaper rash. Ask a doctor.

Stop us and ask doctor if

condition gets worse, or if symptoms last for more than 7 days or clear up and occur again within a few days. Do not begin use of any other hydrocortisone product.

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: ask a doctor

Other information

store at 20 °C to 25 °C (68 °F to 77 °F)

Inactive ingredient

aloe barbadensis (aloe vera) leaf juice, anhydrous citric acid, avena sativa (oat) kernel extract, avena sativa (oat) kernel flour, avena sativa (oat) kernel oil, benzyl alcohol, ceteareth-20, cetostearyl alcohol, cetyl palmitate, cyclopentasiloxane, dimethicone/vinyltrimethylsiloxysilicate, glycerin, isopropyl myristate, isostearyl neopentanoate, methylparaben,
polyoxyl 40 stearate, potassium lactate, purified water, sodium hydroxide, vitamin E

Purpose

Anti-Itch

Content of labeling

Compare to active ingredient in Aveeno 1% Hydrocortisone Anti-Itch Cream with triple Oats

Helps relive severe itch from

Eczema, poison Ivy, Psoriasis, insect bites, seborrheic dermatitis, detergents & soaps Poison oak & sumac

Hydrocortisone Cream 1% with Oats, Aloe & vitamin E

INGREDIENTS AND APPEARANCE

ANTI ITCH 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11383-292
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
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
METHYLPARABEN (UNII: A2I8C7HI9T)
WATER (UNII: 059QF0KO0R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
POTASSIUM LACTATE (UNII: 87V1KMK4QV)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
VINYLTRIMETHYLSILYLOXY SILICATE (UNII: XZ65AY5QAK)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
PEG-40 STEARATE (UNII: ECU18C66Q7)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
OAT KERNEL OIL (UNII: 3UVP41R77R)
DIMETHICONE (UNII: 92RU3N3Y1O)
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
BENZYL ALCOHOL (UNII: LKG8494WBH)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11383-292-01	28 g in 1 TUBE; Type 0: Not a Combination Product	02/10/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	02/10/2013

Labeler - Weeks & Leo Co., Inc. (005290028)

Registrant - Weeks & Leo Co., Inc. (005290028)

Establishment
Name	Address	ID/FEI	Business Operations
Weeks & Leo Co., Inc.		005290028	manufacture(11383-292)