CHIGGEREX 2X MEDICATED- benzocaine 10.0% ointment 
Product Quest Mfg

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredient                             Purpose

Benzocaine  10.0%                         Pain Relief

Uses

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

Warnings
For 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.

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

image description

CHIGGEREX 2X MEDICATED 
benzocaine 10.0% ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64048-1111
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzocaine (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) Benzocaine10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64048-1111-150 g in 1 TUBE; Type 0: Not a Combination Product02/18/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/18/2013
Labeler - Product Quest Mfg (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg927768135manufacture(64048-1111) , label(64048-1111)

Revised: 10/2017
Document Id: 8243fe09-590f-40fd-8ff7-cb266e80e924
Set id: 646bef19-f1f8-4f3c-a2b7-876f7b84ff8c
Version: 1
Effective Time: 20171004
 
Product Quest Mfg