BITE AND STING RELIEF SIGNATURE CARE- benzocaine 5.00% spray

Bite and Sting Relief by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient                                                        Purpose
Benzocaine 5%..........................................................Topical anesthetic

PURPOSE

Uses

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

WARNINGS

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately

DOSAGE & ADMINISTRATION

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BITE AND STING RELIEF  SIGNATURE CARE
benzocaine 5.00% spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21130-337
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
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21130-337-03	85 g in 1 CAN; Type 1: Convenience Kit of Co-Package	03/30/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/30/2018

Labeler - Better Living (009137209)

Registrant - Product Quest Mfg (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg		927768135	manufacture(21130-337) , label(21130-337)