Label: STAPHWASH PLUS- zinc acetate liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 43074-101-01, 43074-101-02 - Packager: Phillips Company
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated August 23, 2010
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DRUG FACTS
Drug Facts
Active Ingredients Purpose
Zinc acetate (.1% by volume) Skin Protectant
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Uses
Temporarily protects injured or exposed skin or mucous membrane surfaces from harmful or annoying stimuli and may help provide relief to such surfaces
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Warnings
For external use only
Keep away from children
Avoid contact with eyes
May be harmful if swallowed or inhaled
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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.
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Directions
Apply to affected skin area and rub gently. Repeat the process as needed.
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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.
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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.
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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
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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
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INGREDIENTS AND APPEARANCE
STAPHWASH PLUS
zinc acetate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43074-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength zinc acetate (UNII: FM5526K07A) (zinc - UNII:J41CSQ7QDS) zinc 0.001 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:43074-101-02 1 in 1 BOTTLE, PLASTIC 1 NDC:43074-101-01 3 mL in 1 BOTTLE, DROPPER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 08/23/2010 Labeler - Phillips Company (612368238) Establishment Name Address ID/FEI Business Operations Phillips Company 612368238 manufacture