ZAPZYT ACNE WASH CLEANSER- salicylic acid gel

Zapzyt Acne Wash Cleanser by

Drug Labeling and Warnings

Zapzyt Acne Wash Cleanser by is a Otc medication manufactured, distributed, or labeled by Focus Consumer Healthcare, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Salicylic Acid 2%

PURPOSE

For the treatment of acne

INDICATIONS & USAGE

For external use only.

WARNINGS

For external use only.

• avoid contact with the eyes. If contact occurs, flush thoroughly with water.
• using other topical acne medications at the same time or immediately following the use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a physician

Do not use

if you are allergic to aspirin or any other pain reliever/fever reducer

with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if

• you have liver disease
  
• the stomach bleeding warning applies to you
  
• you have a history of stomach problems, such as heartburn
  
• you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  
• you are taking a diuretic

Ask a doctor or pharmacist before use

if you are taking a prescription drug for gout, diabetes or arthritis

Stop use and ask a doctor if

• an allergic reaction occurs. Seek medical help right away.
  
• you experience any of the following signs of stomach bleeding:
  • feel faint
    
  • vomit blood
    
  • have bloody or black stools
    
  • have stomach pain that does not get better

• redness or swelling is present
  
• new symptoms occur
  
• pain gets worse or lasts more than 10 days
  
• fever gets worse or lasts more than 3 days
  
• ringing in the ears or loss of hearing occurs

If pregnant or breast-feeding,

ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION

• use twice daily
• add water
• apply to hands
• massage gently to the affected area
• rinse thoroughly

INACTIVE INGREDIENT

Purified water, Disodium EDTA, Chamomile Extract, Aloe Vera Gel, Bioterge AS-40, Cocamidopropyl Betaine, Glucamate DOE-120, Glydant, Sodium Chloride

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ZAPZYT ACNE WASH CLEANSER 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71687-0007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)
DMDM HYDANTOIN (UNII: BYR0546TOW)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
WATER (UNII: 059QF0KO0R)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
CHAMOMILE (UNII: FGL3685T2X)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71687-0007-1	188.5 g in 1 TUBE; Type 0: Not a Combination Product	12/16/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	12/16/2017

Labeler - Focus Consumer Healthcare, LLC (080743737)

Establishment
Name	Address	ID/FEI	Business Operations
Denison Pharmaceuticals, LLC		001207208	manufacture(71687-0007)