CHIGGEREX- benzocaine cream 
Randob Labs,Ltd.

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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Chiggerex®

Drug Facts

Active ingredient

Benzocaine 10.0%

Purpose

Pain Relief

Uses

temporary relief of pain and itching due to

Warnings

For external use only.

When using this product

  • avoid contact with the eyes

Stop use and ask a doctor if

  • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

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

Directions

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.

Inactive ingredients

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

Distributed by:
Randob Labs, Ltd.
Box 440, Cornwall, NY 12518

PRINCIPAL DISPLAY PANEL - 50 g Jar Label

THE ORIGINAL

Chiggerex®
2X Power!
with 10% Benzocaine
MEDICATED OINTMENT

FOR CHIGGER, TICK
AND ALL BUG BITES

FAST, SOOTHING RELIEF
With ALOE VERA
Plus CHAMOMILE

NET WT. 1.75 OZ. (50g)

PRINCIPAL DISPLAY PANEL - 50 g Jar Label
CHIGGEREX 
benzocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52412-350
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine0.1 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
Ascorbic Acid (UNII: PQ6CK8PD0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CAMPHOR, (-)- (UNII: 213N3S8275)  
CHAMOMILE (UNII: FGL3685T2X)  
Cholecalciferol (UNII: 1C6V77QF41)  
Diazolidinyl Urea (UNII: H5RIZ3MPW4)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
CLOVE OIL (UNII: 578389D6D0)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
Methylparaben (UNII: A2I8C7HI9T)  
Octyldodecanol (UNII: 461N1O614Y)  
BLACK OLIVE (UNII: 2M6QWV94OC)  
PEG-2 Stearate (UNII: 94YQ11Y95F)  
PEG-8 Dimethicone (UNII: GIA7T764OD)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Propylparaben (UNII: Z8IX2SC1OH)  
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Sodium Propoxyhydroxypropyl Thiosulfate Silica (UNII: 208G222332)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
Water (UNII: 059QF0KO0R)  
CORN OIL (UNII: 8470G57WFM)  
Product Characteristics
ColorYELLOW (Off-White to Yellow) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52412-350-5050 g in 1 JAR; Type 0: Not a Combination Product02/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/01/2020
Labeler - Randob Labs,Ltd. (061995007)

Revised: 1/2020
Document Id: d3e63adc-f6ed-4b0e-a677-059bf0be567c
Set id: 5e5d84ab-f57f-448d-a4c1-ced38890eec2
Version: 1
Effective Time: 20200108
 
Randob Labs,Ltd.