Zapzyt Pore Cleaning Scrub (Salicylic Acid) Gel [Focus Consumer Healthcare, Llc] -

ZAPZYT PORE CLEANING SCRUB (SALICYLIC ACID) GEL [FOCUS CONSUMER HEALTHCARE, LLC]
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NDC	71687-0005-1
Set ID	607b9705-86c6-087d-e053-2a91aa0addaf
Category	HUMAN OTC DRUG LABEL
Packager	Focus Consumer Healthcare, LLC
Generic Name
Product Class
Product Number
Application Number

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ACTIVE INGREDIENT

Salicylic Acid 2%
PURPOSE

Acne treatment
Uses

Treats acne

Penetrates pores to control acne blemishes

Helps prevent the development of new acne blemishes
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 right after use of this product may increase dryness or irritation of skin. If this occurs, only one medication should be used unless directed by a doctor.
KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away
Directions

wet face

squeeze product into hands

massage over entire face and neck

rinse thoroughly
Other information
- Store at room temperature 15 - 30 degrees C (59 - 86 degreed F)
Inactive ingredients

Purified water, Sodium Cocoyl Isethionate, Sodium Lauroyl Lactylate, Synthetic Wax, Cetyl Alcohol, Glycol Disterate, PEG-6 Caprylic Capric Glycerides, PEG-12 Dimethicone, Ethoxydiglycol, Glycerin, Sodium Hydroxide, Fragrance, Acrylates/C10-30 Akyl Acrylate Cross Polymer, Propylene Gycol, Xanthan Gum, Diazoldrinyl Urea, Menthol, FD&C Blue #1, Iodopropynyl Butylcarbanate
PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ZAPZYT PORE CLEANING SCRUB
salicylic acid gel

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

Ingredient Name	Strength
Inactive Ingredients
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
MENTHOL (UNII: L7T10EIP3A)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
WATER (UNII: 059QF0KO0R)
SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)
PARAFFIN (UNII: I9O0E3H2ZE)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
PEG-6 CAPRYLIC/CAPRIC GLYCERIDES (UNII: GO50W2HWO8)
PEG-12 DIMETHICONE (UNII: ZEL54N6W95)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
XANTHAN GUM (UNII: TTV12P4NEE)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71687-0005-1	141 g in 1 TUBE; Type 0: Not a Combination Product	12/16/2017

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

Labeler - Focus Consumer Healthcare, LLC (080743737)

Name	Address	ID/FEI	Business Operations
Establishment
Denison Pharmaceuticals, LLC		001207208	manufacture(71687-0005)

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