STAPHWASH PLUS - zinc acetate liquid 
Phillips Company

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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DRUG FACTS

DRUG FACTS

Drug Facts
Active Ingredients                            Purpose
Zinc acetate (.1% by volume)           Skin Protectant
________________________________________
Uses
Temporarily protects injured or exposed skin or mucous membrane surfaces from harmful or annoying stimuli and may help provide relief to such surfaces
________________________________________
Warnings
For external use only   
Keep away from children   
Avoid contact with eyes  
May be harmful if swallowed or inhaled
________________________________________
Ask a doctor
If symptoms last for more than 7 days or clear up and recur within a few days.
If the conditions do not improve.  
Before use on children under 2 years.
Before use if you are allergic to any ingredients listed on this label.
________________________________________
Directions
Apply to affected skin area and rub gently.  Repeat the process as needed.
________________________________________
Other information  
StaphWash Plus is an OTC skin protectant drug product for human use.  Store at 40 to 120 degrees F.  Net contents:  3 mL (dropper bottle).  This product contains no alcohol; no animal products; no biological products.              
________________________________________
Inactive ingredients 
Water, color, glycerin, hydroxethylcellulose, chlor-hexidine gluconate, glucono delta lactone, methylparaben, sodium hydroxide,sodium dodecylbenzene sulfonate, ascorbic acid, magnesium stearate, silica and stearic acid.                       
________________________________________
Questions and Side effects
StaphWash Plus use results in no known side effects when used according to directions.  Phillips Company, 311 Chickasaw Street, Millerton, OK USA 74750;    Tel.  580-746-2430  
Email address:  PhillipsCompany@cox.net


ACTIVE INGREDIENTS

Active Ingredients                            Purpose
Zinc acetate (.1% by volume)           Skin Protectant

ASK DOCTOR

Ask a doctor
If symptoms last for more than 7 days or clear up and recur within a few days.
If the conditions do not improve.  
Before use on children under 2 years.
Before use if you are allergic to any ingredients listed on this label.

DO NOT USE


Warnings
For external use only   
Keep away from children   
Avoid contact with eyes  
May be harmful if swallowed or inhaled

CHILDREN

 
Keep away from children   
Avoid contact with eyes  
May be harmful if swallowed or inhaled

PURPOSE


Active Ingredients                            Purpose
Zinc acetate (.1% by volume)           Skin Protectant

STOP USE


If symptoms last for more than 7 days or clear up and recur within a few days.
If the conditions do not improve.   
Before use on children under 2 years.
Before use if you are allergic to any ingredients listed on this label.

WHEN USING


For external use only   
Avoid contact with eyes  
May be harmful if swallowed or inhaled
If symptoms last for more than 7 days or clear up and recur within a few days.
If the conditions do not improve.  
Store at 40 to 120 degrees F.

WARNINGS



Warnings
For external use only   
Keep away from children   
Avoid contact with eyes  
May be harmful if swallowed or inhaled
StaphWash Plus use results in no known side effects when used according to directions. 

Phillips Company, 311 Chickasaw Street, Millerton, OK USA 74750;    Tel.  580-746-2430  
Email address:  PhillipsCompany@cox.net

DOSAGE & ADMINISTRATION

Uses
Temporarily protects injured or exposed skin or mucous membrane surfaces from harmful or annoying stimuli and may help provide relief to such surfaces

Directions
Apply to affected skin area and rub gently.  Repeat the process as needed.

USE

Uses
Temporarily protects injured or exposed skin or mucous membrane surfaces from harmful or annoying stimuli and may help provide relief to such surfaces

Apply to affected skin area and rub gently.  Repeat the process as needed.

INACTIVE INGREDIENTS

Inactive ingredients
Water, color, glycerin, hydroxethylcellulose, chlor-hexidine gluconate, glucono delta lactone, methylparaben, sodium hydroxide,sodium dodecylbenzene sulfonate, dimethyl sulfoxide, witch hazel, ascorbic acid, magnesium stearate, silica and stearic acid. 

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STAPHWASH PLUS 
zinc acetate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43074-105
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
zinc acetate (UNII: FM5526K07A) (zinc - UNII:J41CSQ7QDS) zinc0.001 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
dipropylene glycol (UNII: E107L85C40)  
water (UNII: 059QF0KO0R)  
glycerin (UNII: PDC6A3C0OX)  
chlorhexidine gluconate (UNII: MOR84MUD8E)  
calcium gluconate (UNII: SQE6VB453K)  
methylparaben (UNII: A2I8C7HI9T)  
sodium hydroxide (UNII: 55X04QC32I)  
sorbic acid (UNII: X045WJ989B)  
magnesium stearate (UNII: 70097M6I30)  
stearic acid (UNII: 4ELV7Z65AP)  
witch hazel (UNII: 101I4J0U34)  
sodium dodecylbenzenesulfonate (UNII: 554127163Y)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43074-105-021 in 1 BOTTLE, PLASTIC
1NDC:43074-105-013 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34708/23/2010
Labeler - Phillips Company (612368238)
Establishment
NameAddressID/FEIBusiness Operations
Phillips Company612368238manufacture

Revised: 8/2010
Document Id: 3b27d0ae-6e49-4b49-b67e-26a38fd9c76f
Set id: 202f0eaf-e8e6-4632-b916-18d5d759dda8
Version: 7
Effective Time: 20100823
 
Phillips Company