FLOCEAN ANTI-ITCH- benzocaine 5%anti-itch cream

Flocean ANTI-ITCH by

Drug Labeling and Warnings

Flocean ANTI-ITCH by is a Otc medication manufactured, distributed, or labeled by Jiangxi Hemei Pharmaceutical Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

FLOCEAN ANTI-ITCH 
benzocaine 5%anti-itch cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84010-017
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
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84010-017-01	28 g in 1 BOTTLE; Type 0: Not a Combination Product	06/25/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	06/25/2024

Labeler - Jiangxi Hemei Pharmaceutical Co., Ltd (724892056)

Establishment
Name	Address	ID/FEI	Business Operations
Jiangxi Hemei Pharmaceutical Co., Ltd		724892056	label(84010-017) , manufacture(84010-017)