MAXIMUM STRENGTH ANTI-ITCH- hydrocortisone 1% spray

Maximum Strength Anti-Itch by

Drug Labeling and Warnings

Maximum Strength Anti-Itch by is a Otc medication manufactured, distributed, or labeled by Quality Choice, Product Quest Mfg. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient                                Purpose

Hydrocortisone - 1.00%                       Anti-itch

PURPOSE

Uses

Temporarily relieves itching associated with minor skin irritation and rashes due to:

eczema           poison ivy, oak and sumac         cosmetics

psoriasis         soaps and detergents                  jewelry

insect bites     seborrheic dermatitis

Warnings

For external use only

Flammable: Do not use while smoking or near heat or flame

When using this product

Avoid contact with the eyes. If condition worsens, or if symptoms
persist for more than 7 days or clear up and occur again within a
few days, stop use of this product and do not begin use of any
other hydrocortisone product unless you have consulted a doctor.
Do not use for the treatment of diaper rash. Consult a doctor.
Do not puncture or incinerate. Contents under pressure. Do not
store at temperatures above 120˚F.F

Ask doctor before use if you are using any other hydrocortisone product

Keep out of reach of the children

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

Directions

shake well
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

to apply to face, spray into palm of hand and gently apply

Inactive ingredients

Citric Acid, Disodium EDTA, Glycerin, Poloxamer 188, Polysorbate 20, SD Alcohol 40-B, Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MAXIMUM STRENGTH ANTI-ITCH 
hydrocortisone 1% spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63868-782
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
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
Glycerin (UNII: PDC6A3C0OX)
Poloxamer 188 (UNII: LQA7B6G8JG)
Polysorbate 20 (UNII: 7T1F30V5YH)
ALCOHOL (UNII: 3K9958V90M)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63868-782-03	85 g in 1 CAN; Type 0: Not a Combination Product	04/07/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	04/07/2014

Labeler - Quality Choice (011920774)

Registrant - Product Quest Mfg (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg		927768135	manufacture(63868-782) , label(63868-782)