Zapzyt Pore Clearing Scrub

Drug Labeling and Warnings

Drug Details [pdf]

ZAPZYT PORE CLEANING SCRUB- salicylic acid gel 
Denison Pharmaceuticals, LLC

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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Zapzyt Pore Clearing Scrub

Acne treatment

Salicylic Acid 2%

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.

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

Keep out of reach of children.

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

PRINCIPAL DISPLAY PANEL

ZAPZYT PORE CLEANING SCRUB 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0295-1076
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: 0295-1076-21	141 g in 1 TUBE; Type 0: Not a Combination Product	01/31/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	01/31/2018	08/06/2019

Labeler - Denison Pharmaceuticals, LLC (001207208)

Establishment
Name	Address	ID/FEI	Business Operations
Denison Pharmaceuticals, LLC		001207208	manufacture(0295-1076)

Revised: 8/2019

Document Id: 8f783c34-585e-db5b-e053-2995a90a5b4e

34390-5

Set id: 80c3a23b-12c5-0cfa-e053-2a91aa0a88f8

Version: 2

Effective Time: 20190806