FLOCEAN ANTI-ITCH- benzocaine 5%anti-itch cream 
Jiangxi Hemei Pharmaceutical Co., Ltd

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84010-017

Active Ingredient

Benzocaine 5%

Purpose

External analgesic

Use

temporarily relieves itching

Warnings

For external use only

Do not use

if you have a vaginal discharge. Consult a physician.

When Using

Avoid contact with eyes

Stop Use

condition worsens, or if symptoms persist formore than 7 days, or clear up and occur again within a few days Do not applyover large areas of the body

Ask Doctor

condition worsens, or if symptoms persist formore than 7 days, or clear up and occur again within a few days Do not applyover large areas of the body

Keep Oot Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

adults and children 12 years and older apply a fingertipamount (approximately 1-inch strip) to affected area not more than 3 to 4times daily, Clean nozzle of tube by wiping thoroughly before replacing cap.Keep cap tightly closed between uses.

Other information

children under 12 years consult a doctor

Inactive ingredients

water ,Glycerol ,Propylene Glycol ,Polydimethylsiloxane ,Trolamine,Borneol,MENTHAPIPERITA,Methylparaben ,Chlorhexidine

PRINCIPAL DISPLAY PANEL

1

FLOCEAN ANTI-ITCH 
benzocaine 5%anti-itch cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84010-017
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
METHYLPARABEN (UNII: A2I8C7HI9T)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TROLAMINE (UNII: 9O3K93S3TK)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
BORNEOL (UNII: M89NIB437X)  
MENTHA PIPERITA (UNII: 79M2M2UDA9)  
CHLORHEXIDINE (UNII: R4KO0DY52L)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:84010-017-0128 g in 1 BOTTLE; Type 0: Not a Combination Product06/25/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01706/25/2024
Labeler - Jiangxi Hemei Pharmaceutical Co., Ltd (724892056)
Establishment
NameAddressID/FEIBusiness Operations
Jiangxi Hemei Pharmaceutical Co., Ltd724892056label(84010-017) , manufacture(84010-017)

Revised: 6/2024
Document Id: 1bb2bdac-0928-f699-e063-6394a90aa898
Set id: 1bb2bdac-0927-f699-e063-6394a90aa898
Version: 1
Effective Time: 20240625
 
Jiangxi Hemei Pharmaceutical Co., Ltd