BITE AND STING RELIEF- benzocaine - 5.00% cream

Bite and Sting relief by

Drug Labeling and Warnings

Bite and Sting relief by is a Otc medication manufactured, distributed, or labeled by Top care, 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

Water
PEG-2 Stearate
PEG-2 Stearate SE
SD Alcohol 40
Polyethylene
Hydrocortisone
Methylparaben
Aloe Barbadensis Leaf Extract
Propylparaben
Chamomilla Recutita (Matricaria) Flower Extract
Propylene Glycol
Diazolidinyl Urea
Disodium EDTA
Olea Europaea (Olive) Fruit Oil
Camphor
Menthol
Mentha Piperita (Peppermint) Oil
Eugenia Caryophyllus (Clove) Flower Oil
Papain

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BITE AND STING RELIEF 
benzocaine - 5.00% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-718
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 g

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: 36800-718-02	1 in 1 CARTON	08/06/2012
1		50 g 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	08/06/2012

Labeler - Top care (006935977)

Registrant - Product Quest Mfg. (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg.		927768135	manufacture(36800-718) , label(36800-718)