BITE RELIEF SCHERER LABS- benzocaine - 5.00% cream 
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 ingredients                   Purpose

Benzocaine                                5.00%

Uses

For temporarily relief of pain and itching associated with insect bites

Warning
For external use only

When using this product avoid contact with eyes and mucous membranes

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

Keep out of reach of the children
If product is swallowed, get medical help or contact a Poison Control Center right away
In case of accidental ingestion, seek professional or contact a Poison Control Center immediately.

Direction

Adults and children 2 years of age and older: • apply to the affected area nor mre than 3 to 4 times daily. Children under 2 years of age: consult a doctor

Inactive ingredients

Acrylates/Dimethicone Copolymer
BHT
Bisabolol
C12-15 Alkyl Benzoate
Capryloyl Glycine
Caprylyl Glycol
Cedrus Atlantica Bark Extract
Cetyl Dimethicone
Chlorphenesin
Cinnamomum Zeylanicum Bark Extract
Cyclopentasiloxane
Disodium EDTA
Ethylhexyl Stearate
Ethylhexylglycerin
Glycerin
Hydrated Silica
Mannan
Neopentyl Glycol Diheptanoate
Phenoxyethanol
Polyester-7
Polyester-8
Portulaca Oleracea Extract
Propylene Glycol
Sarcosine
Sodium Polyacrylate
Steareth-100
Steareth-2
Styrene/Acrylates Copolymer
Trideceth-6
Water
Xanthan Gum

image descriptionimage description

BITE RELIEF  SCHERER LABS
benzocaine - 5.00% cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64048-7336
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzocaine (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) Benzocaine5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
PEG-2 Stearate (UNII: 94YQ11Y95F)  
ALCOHOL (UNII: 3K9958V90M)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
Hydrocortisone (UNII: WI4X0X7BPJ)  
Methylparaben (UNII: A2I8C7HI9T)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Propylparaben (UNII: Z8IX2SC1OH)  
CHAMOMILE (UNII: FGL3685T2X)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Diazolidinyl Urea (UNII: H5RIZ3MPW4)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
Menthol (UNII: L7T10EIP3A)  
Peppermint (UNII: V95R5KMY2B)  
CLOVE OIL (UNII: 578389D6D0)  
Papain (UNII: A236A06Y32)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64048-7336-21 in 1 CARTON02/10/2012
152 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/10/2012
Labeler - Product Quest Mfg. (927768135)
Registrant - Product Quest Mfg. (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg.927768135manufacture(64048-7336) , label(64048-7336)

Revised: 3/2018
Document Id: 42235b23-8f69-4990-883d-62fafd77bc03
Set id: 3a50ebc1-8064-4f34-ad13-426616586147
Version: 3
Effective Time: 20180329
 
Product Quest Mfg.