SIGNATURE CARE BITE AND STING RELIEF- benzocaine spray 
Safeway

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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Signature Care Bite and Sting Relief Spray Benzocaine 5%

Active Ingredient

Benzocaine 5%

Purpose

External analgesic

Uses For the Temporary Relief of pain and itching associated with insect bites

Warnings

For external use only

When using this product, avoid contact with eyes and mucous membranes., do not apply to wound or damage skin, do not bandage, do not use with heating pad or device.

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

shake well, adults and children 2 years of age and older: Apply to affected area no more than 3 to 4 times daily. Wash hands with soap. 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

Signature Care Bite & Sting Relief Spray

SIGNATURE CARE BITE AND STING RELIEF 
benzocaine spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-143
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM PROPOXYHYDROXYPROPYL THIOSULFATE SILICA (UNII: 208G222332)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CLOVE OIL (UNII: 578389D6D0)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CORN OIL (UNII: 8470G57WFM)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
PEG-8 DIMETHICONE (UNII: GIA7T764OD)  
CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
CHOLECALCIFEROL (UNII: 1C6V77QF41)  
ALCOHOL (UNII: 3K9958V90M)  
CHAMOMILE (UNII: FGL3685T2X)  
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:21130-143-0185 g in 1 CAN; Type 0: Not a Combination Product03/11/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/11/2020
Labeler - Safeway (009137209)
Establishment
NameAddressID/FEIBusiness Operations
Inspec Solutions LLC081030372manufacture(21130-143)

Revised: 3/2020
Document Id: a09782a2-ea51-7938-e053-2995a90af88d
Set id: a09782a2-ea50-7938-e053-2995a90af88d
Version: 1
Effective Time: 20200311
 
Safeway