BITE AND STING RELIEF- benzocaine - 5.00% cream
Top care

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

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

image description

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	08/06/2012

Labeler - Top care (006935977)

Registrant - Product Quest Mfg. (927768135)