CHIGGEREX 2X MEDICATED- benzocaine 10.0% ointment

Chiggerex 2X Medicated by

Drug Labeling and Warnings

Chiggerex 2X Medicated by is a Otc medication manufactured, distributed, or labeled by Product Quest Mfg. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient                             Purpose

Benzocaine  10.0%                         Pain Relief

PURPOSE

Uses

Temporarily relieves pain and itching due tochigger bites, red bug bites, ticks, mosquito bites

WarningsFor external use only

When using this product avoid contact with the eyes

Stop use and ask a doctor if rash occurs
condition worsens
symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of children. If swallowed, contact a Poison Control Center immediately.

KEEP OUT OF REACH OF CHILDREN

Directions

adults and children 12 years of age and older: apply to affected area, not more than 3 to 4 times daily. Children under 2 years of age: consult a doctor

Inactive ingredients

Water
PEG-2 Stearate SE, PEG-2 Stearate
Olea Europaea (Olive) Fruit Extract
Aloe Barbadensis Leaf Juice
Methylparaben
Diazolidinyl Urea
Mentha Piperita (Peppermint) Oil
Eugenia Caryophyllus (Clove) Flower Oil
Propylparaben
Chamomilla Recutita (Matricaria) Flower Extract
PEG-8 Dimethicone, Zea Mays (Corn) Oil, Propylene Glycol, Octyldodecanol, Tocopheryl
Acetate, Ascorbic Acid, Retinyl Palmitate, Pyridoxine HCl, Cholecalciferol, Sodium
Propoxyhydroxypropyl Thiosulfate Silica
Fragrance
Disodium EDTA
Camphor

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CHIGGEREX 2X MEDICATED 
benzocaine 10.0% ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64048-1111
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzocaine (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	Benzocaine	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
PEG-2 STEARATE (UNII: 94YQ11Y95F)
BLACK OLIVE (UNII: 2M6QWV94OC)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
Methylparaben (UNII: A2I8C7HI9T)
Diazolidinyl Urea (UNII: H5RIZ3MPW4)
PEPPERMINT OIL (UNII: AV092KU4JH)
CLOVE OIL (UNII: 578389D6D0)
Propylparaben (UNII: Z8IX2SC1OH)
CHAMOMILE (UNII: FGL3685T2X)
PEG-8 DIMETHICONE (UNII: GIA7T764OD)
CORN OIL (UNII: 8470G57WFM)
Propylene Glycol (UNII: 6DC9Q167V3)
Octyldodecanol (UNII: 461N1O614Y)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
Ascorbic Acid (UNII: PQ6CK8PD0R)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)
Cholecalciferol (UNII: 1C6V77QF41)
SODIUM PROPOXYHYDROXYPROPYL THIOSULFATE SILICA (UNII: 208G222332)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64048-1111-1	50 g in 1 TUBE; Type 0: Not a Combination Product	02/18/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/18/2013

Labeler - Product Quest Mfg (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg		927768135	manufacture(64048-1111) , label(64048-1111)