NEILMED ANTI-ITCH- anti-itch spray spray

NeilMed Anti-Itch by

Drug Labeling and Warnings

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

Drug Details [pdf]

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

Warnings:

For external use only.
Flammable: Do not use while smoking or near heat or flame
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 seek 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
Ask a doctor before use if you are using any other hydrocortisone or corticosteroid product.
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.
Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Inactive Ingredients:

Citric Acid, Disodium EDTA, Glycerin,Poloxamer 407, Polysorbate 20, SD Alcohol 40-B,USP grade purified Water.

Uses:

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

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

Keep out of reach of children.

If swallowed, get medical help or contact a poison control center right away.

Drug Facts: Purpose

Anti-itch

Drug Facts:

Active Ingredient
Hydrocortisone 1.0%

NeilMed Anti Itch Spray

INGREDIENTS AND APPEARANCE

NEILMED ANTI-ITCH 
anti-itch spray spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13709-239
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
EDETATE DISODIUM (UNII: 7FLD91C86K)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
ALCOHOL (UNII: 3K9958V90M)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
GLYCERIN (UNII: PDC6A3C0OX)
POLOXAMER 407 (UNII: TUF2IVW3M2)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13709-239-01	90 g in 1 CAN; Type 0: Not a Combination Product	11/11/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	11/11/2020

Labeler - NeilMed Pharmaceuticals Inc. (799295915)

Establishment
Name	Address	ID/FEI	Business Operations
NeilMed Pharmaceuticals, Inc.		799295915	manufacture(13709-239)