BITE RELIEF SCHERER LABS- benzocaine - 5.00% cream

Bite relief by

Drug Labeling and Warnings

Bite relief by is a Otc medication manufactured, distributed, or labeled by Product Quest Mfg.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients                   Purpose

Benzocaine                                5.00%

PURPOSE

Uses

For temporarily relief of pain and itching associated with insect bites

WarningFor 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 CHILDREN

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BITE RELIEF  SCHERER LABS
benzocaine - 5.00% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64048-7336
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzocaine (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	Benzocaine	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64048-7336-2	1 in 1 CARTON	02/10/2012
1		52 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/10/2012

Labeler - Product Quest Mfg. (927768135)

Registrant - Product Quest Mfg. (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg.		927768135	manufacture(64048-7336) , label(64048-7336)