PUMICE CLEANSING SCRUB- 2.5% BENZOYL PEROXIDE- benzoyl peroxide soap

Pumice Cleansing Scrub- 2.5% Benzoyl Peroxide by

Drug Labeling and Warnings

Pumice Cleansing Scrub- 2.5% Benzoyl Peroxide by is a Otc medication manufactured, distributed, or labeled by Only Yourx, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INACTIVE INGREDIENT

Inactive Ingredients: Water, Sodium C14-16 Alpha Olefin Sulfonate, Microcrystalline Cellulose, Disodium, Cocoamphodiacetate, Glycerin, ethoxydiglycol, Acrylates C10-30 Alkyl Acrylates Crosspolymer, Potassium Sorbate, Polysorbate 20, Sodium Hydroxide, Ethylhexylglycerin, Phenoxyethanol

ACTIVE INGREDIENT

Active Ingredients: Benzoyl Peroxide 2.5%

PURPOSE

Purpose: Acne Medication; a gentle medicated exfoliant wash

INDICATIONS & USAGE

Uses: Treats acne and helps prevent new acne blemishes from forming, kills acne bacteria

WARNINGS

WARNINGS: For External Use Only

DO NOT USE

Do not use: if you have very sensitive skin; if you are sensitive to benzoyl peroxide

WHEN USING

When using this product: avoid sun exposure and use sunscreen; using other acne medications at the same time may cause excessive dryness or irritation of te skin; may bleach hair and fabrics; do not use in or near eyes, lips and mouth

ASK DOCTOR

Consult a doctor: if excessive irritation occurs

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center

DOSAGE & ADMINISTRATION

Directions: use 1 to 3 times daily on affected areaws to help prevent breakouts; apply using fingertips, using circular motions; gently scrub into a lather; rinse off thorouhly with warm water; if going outside, use a sunscreen

OTHER SAFETY INFORMATION

Other Information: store at room temperature; keep tightly closed

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PUMICE CLEANSING SCRUB- 2.5% BENZOYL PEROXIDE 
benzoyl peroxide soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70367-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	2.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHOXYDIGLYCOL BEHENATE (UNII: N76ISC4ZZO)
GLYCERIN (UNII: PDC6A3C0OX)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70367-004-04	120 mL in 1 TUBE; Type 0: Not a Combination Product	08/26/2014
2	NDC: 70367-004-08	240 mL in 1 TUBE; Type 0: Not a Combination Product	08/26/2014
3	NDC: 70367-004-75	22.18 mL in 1 TUBE; Type 0: Not a Combination Product	08/26/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	08/26/2014

Labeler - Only Yourx, Inc. (089207519)