SHUNFA ANTI-BACTERIA SPRA- didecyldimethyl ammonium,triclosan, borneol, benzalkonium bromide spray
Chengdu Shunfa Disinfection and Washing Technology Co Ltd

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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SHUNFA ANTI-BACTERIA SPRAY

ACTIVE INGREDIENTS

Didecyldimethyl Ammonium 0.3%

Triclosan 0.3%

Borneol 0.4%

Benzalkonium Bromide 0.3%

PURPOSES

Antibacterial

KEEP OUT OF REACH OF CHILDREN.

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

DO NOT USE

if you are allergic to any of the ingredients.

WHEN USING THIS DEVICE

do not get into eyes. If eye contact occurs, rinse thoroughly with water.

STOP USE AND ASK A DOCTOR IF

irritation or redness develops, and continues for more than 72 hours.

USES

Uses spray to reduce bacteria on the skin.

WARNINGS

For external use only.

DIRECTIONS

for adults and children 2 years and olde, apply to human body, allow to dry without wiping, ask a doctor before using on children under 2 years.

INACTIVE INGREDIENTS

Polyethylene Glycol, Menthol, Water

SHUNFA ANTI-BACTERIA SPRA
didecyldimethyl ammonium,triclosan, borneol, benzalkonium bromide spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58686-013
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIDECYLDIMETHYLAMMONIUM (UNII: Z7F472XQPA) (DIDECYLDIMETHYLAMMONIUM - UNII:Z7F472XQPA)	DIDECYLDIMETHYLAMMONIUM	3 mg in 1000 mg
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	3 mg in 1000 mg
BENZALKONIUM BROMIDE (UNII: 151T1GQ42D) (BENZALKONIUM BROMIDE - UNII:151T1GQ42D)	BENZALKONIUM BROMIDE	3 mg in 1000 mg
BORNEOL (UNII: M89NIB437X) (BORNEOL - UNII:M89NIB437X)	BORNEOL	4 mg in 1000 mg

Ingredient Name	Strength
Inactive Ingredients
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)	100 mg in 1000 mg
MENTHOL (UNII: L7T10EIP3A)	3 mg in 1000 mg
WATER (UNII: 059QF0KO0R)	800 mg in 1000 mg

#	Item Code	Package Description
Packaging
1	NDC:58686-013-01	30 mg in 1 BOTTLE, SPRAY
2	NDC:58686-013-02	5 mg in 1 BOTTLE, SPRAY

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	10/30/2005

Labeler - Chengdu Shunfa Disinfection and Washing Technology Co Ltd (527046468)

Registrant - Chengdu Shunfa Disinfection and Washing Technology Co Ltd (527046468)

Name	Address	ID/FEI	Business Operations
Establishment
Chengdu Shunfa Disinfection and Washing Technology Co Ltd		527046468	manufacture(58686-013)