Anti Itch by Neilmed Pharmaceuticals Inc. ANTI ITCH spray

Anti Itch by

Drug Labeling and Warnings

Anti Itch by is a Otc medication manufactured, distributed, or labeled by Neilmed Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS - Active Ingredient

Hydrocortisone 1.0%

Purpose

Anti-Itch

Uses

Temporarily alleviates itching associated with minor skin irritation, inflammation and rashes due to:

• Eczema
• Poison ivy, oak and sumac
• Psoriasis
• Soaps and detergents
• Cosmetics
• Jewelry
• Insect bites
• Seborheic dermatitis

Warnings

For external use only.
Flammable: Do not use while smoking or near heat or flame

Warnings : Do not use:

In or near the eyes; for diaper rash ask a doctor. In case of an accidental exposure rinse with water or saline immediately, remove contact lenses and sesk medical help for any persistent symptoms. Use only as directed. Do not puncture or incinerate. Contents under pressure. Avoid long term storage above 104°F. Do not store at temperatures above 120°F.

Warnings : Ask a doctor before use if

you are using any other hydrocortisone or corticosteroid product.

Warnings : Stop use and ask doctor

if condition worsens or does not improve within 7 days, or clears up and occurs again within a few days.

Warnings: Keep out of reach of children

If swallowed, get medical help or contact a poison control center right away. 1-800-222-1222

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 407, Polysorbate 20, SD Alcohol 40-B, USP grade purified Water.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ANTI ITCH 
anti itch spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13709-327
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
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
WATER (UNII: 059QF0KO0R)
POLOXAMER 407 (UNII: TUF2IVW3M2)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 20 (UNII: 7T1F30V5YH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13709-327-01	1 in 1 CARTON	03/06/2025
1		90 g in 1 CAN; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	03/06/2025

Labeler - Neilmed Pharmaceuticals Inc. (799295915)

Establishment
Name	Address	ID/FEI	Business Operations
Neilmed Pharmaceuticals Inc.		799295915	manufacture(13709-327)