BITE AND STING RELIEF SIGNATURE CARE- benzocaine 5.00% spray 
Better Living

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 5%..........................................................Topical anesthetic

Uses

For the temporary relief of pain and itching associated with insect bites.

Warnings
For external use only.

Flammable: Do not use while smoking or near heat or flame
When using this product • use only as directed  • avoid contact with eyes

Do not puncture or incenerate. Contents under pressure. Do not store at temperature above 120F
Stop use and ask a doctor if • condition worsens • 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 immediately

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: consult a doctor.

Inactive ingredients

Aloe Barbadensis Leaf Extract
Ascorbic Acid
Camphor
Chamomilla Recutita (Matricaria) Flower Extract
Cholecalciferol
Diisopropyl Adipate
Eugenia Caryophyllus (Clove) Flower Oil
Fragrance
Mentha Piperita (Peppermint) Oil
Octyldodecanol
Olea Europaea (Olive) Fruit Oil
PEG-8 Dimethicone
Propylene Glycol
Pyridoxine HCl
Retinyl Palmitate
SD Alcohol 40
Silica
Sodium Propoxyhydroxypropyl Thiosulfate Silica
Tocopheryl Acetate
Zea Mays (Corn) Oil

image description

BITE AND STING RELIEF  SIGNATURE CARE
benzocaine 5.00% spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-337
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzocaine (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) Benzocaine5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Ascorbic Acid (UNII: PQ6CK8PD0R)  
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
CHAMOMILE (UNII: FGL3685T2X)  
Cholecalciferol (UNII: 1C6V77QF41)  
Diisopropyl Adipate (UNII: P7E6YFV72X)  
CLOVE OIL (UNII: 578389D6D0)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
Octyldodecanol (UNII: 461N1O614Y)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
PEG-8 Dimethicone (UNII: GIA7T764OD)  
Propylene Glycol (UNII: 6DC9Q167V3)  
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
ALCOHOL (UNII: 3K9958V90M)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Sodium Propoxyhydroxypropyl Thiosulfate Silica (UNII: 208G222332)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CORN OIL (UNII: 8470G57WFM)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:21130-337-0385 g in 1 CAN; Type 1: Convenience Kit of Co-Package03/30/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/30/2018
Labeler - Better Living (009137209)
Registrant - Product Quest Mfg (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg927768135manufacture(21130-337) , label(21130-337)

Revised: 1/2018
Document Id: e10fdf23-f6ae-476c-8bf0-766465f903f3
Set id: 2d5d3ffc-78d2-4d60-8e9d-e326d11d053c
Version: 1
Effective Time: 20180118
 
Better Living