ZAPZYT PORE CLEANING SCRUB- salicylic acid gel

Zapzyt Pore Cleaning Scrub by

Drug Labeling and Warnings

Zapzyt Pore Cleaning Scrub by is a Otc medication manufactured, distributed, or labeled by Focus Consumer Healthcare, LLC, Denison Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71687-0005
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
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71687-0005-1	141 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(71687-0005)