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NDC 46122-0653-34 Bite and Sting Relief 5 g/100g Details

Bite and Sting Relief 5 g/100g

Bite and Sting Relief is a TOPICAL SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by Amerisource Bergen LLC. The primary component is BENZOCAINE.

Product Information

NDC	46122-0653
Product ID	46122-653_d5cafb51-297a-f456-e053-2a95a90af155
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Bite and Sting Relief
Proprietary Name Suffix	GNP
Non-Proprietary Name	Benzocaine
Product Type	HUMAN OTC DRUG
Dosage Form	SPRAY
Route	TOPICAL
Active Ingredient Strength	5
Active Ingredient Units	g/100g
Substance Name	BENZOCAINE
Labeler Name	Amerisource Bergen LLC
Pharmaceutical Class	Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2023-12-31

Package

Package Images

NDC 46122-0653-34 (46122065334)

Pricing Information	N/A
NDC Package Code	46122-653-34
Billing NDC	46122065334
Package	85 g in 1 PACKAGE (46122-653-34)
Marketing Start Date	2021-01-18
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 3c9689cc-f597-4337-a45c-632959d357dc Details

Active ingredient Purpose

Benzocaine 5.0% ....................................... Pain Relief

SPL UNCLASSIFIED SECTION

Uses

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

Warnings For external use only.

Flammable: Do not use while smoking or near heat or flame

When using this product• avoid contact with the eyes• use only as directed.• do not puncture or incinerate.

Contents under pressure.

Do not store at temperatures above 120°F.

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 the reach of children.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

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: Ask a doctor.

Inactive ingredients

Aloe Barbadensis Leaf Juice 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,

PE -8 Dimethicone, Propylene lycol, Pyridoxine HCI, Retinyl Palmitate, SD Alcohol 40, Silica, Sodium Propoxyhydroxypropyl Thiosulfate Silica,

Tocopheryl Acetate, Zea Mays (Corn) Oil.

Questions?

888-793-8450

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BITE AND STING RELIEF GNP

benzocaine spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:46122-653
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
ALOE ARBORESCENS FLOWER (UNII: U449SE7IPV)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
MATRICARIA CHAMOMILLA LEAF (UNII: 6I9LN466F0)
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:46122-653-34	85 g in 1 PACKAGE; Type 0: Not a Combination Product	01/18/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	01/18/2021

Labeler - Amerisource Bergen LLC (007914906)

Name	Address	ID/FEI	Business Operations
Establishment
Inspec Solutions LLC		081030372	manufacture(46122-653)

Revised: 1/2022

Document Id: d5cafb51-297a-f456-e053-2a95a90af155

Set id: 3c9689cc-f597-4337-a45c-632959d357dc

Version: 3

Effective Time: 20220117