Itch Relief Gel by Humco Holding Group, Inc ITCH RELIEF GEL gel

Itch Relief Gel by

Drug Labeling and Warnings

Itch Relief Gel by is a Otc medication manufactured, distributed, or labeled by Humco Holding Group, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOSAGE & ADMINISTRATION

Do not use more often than directed.

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.

WARNINGS

For external use only.

INACTIVE INGREDIENT

Camphor, Citric Acid, Diazolidnyl Urea, Glycerin, Hydroxypropyl Methylcellulose, Methylparaben, Propylene Glycol, Propylparaben, SD Alcohol 38-B, Sodium Citrate, Purified Water.

INDICATIONS & USAGE

Temporarily relieves pain due to: Minor burns, insect bites, sunburn, minor skin irritation, minor cuts, scrapes, rashes due to poison ivy, poison oak and poison sumac.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

PURPOSE

External Analgesic

ACTIVE INGREDIENT

Diphenhydramine HCl 2%

Equate Label

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INGREDIENTS AND APPEARANCE

ITCH RELIEF GEL 
itch relief gel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0395-9134
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	2 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
ALCOHOL (UNII: 3K9958V90M)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0395-9134-94	118 mL in 1 CONTAINER; Type 0: Not a Combination Product	12/20/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	12/20/2018

Labeler - Humco Holding Group, Inc (825672884)

Registrant - Humco Holding Group, Inc (825672884)

Establishment
Name	Address	ID/FEI	Business Operations
Humco Holding Group, Inc		825672884	manufacture(0395-9134) , label(0395-9134) , pack(0395-9134) , analysis(0395-9134)