OKAY NOURISHING PEPPERMINT SCRUB AND MASK- salicylic acid cream

OKAY Nourishing Peppermint Scrub and Mask by

Drug Labeling and Warnings

OKAY Nourishing Peppermint Scrub and Mask by is a Otc medication manufactured, distributed, or labeled by Xtreme Tools International, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Salicylic Acid……………….2%

Purpose

Acne Treatment

Use

for the treatment of acne

Warnings

For External use only

When using this product

Skin irritation and dryness may occur if using in conjunction with another acne medication.
Stop using if irritation occurs, or only use one acne medication at a time.

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

Directions

Moisten skin with water and apply over face using fingertips. Rinse with warm water. For best results use 3-4 times a week. Avoid direct contact with eyes. If contact occurs rinse thoroughly with water.

Inactive ingredients

Deionized water, Glyceryl Stearate, Propylene Glycol, Cetearyl Alcohol, Cocamidopropyl Betaine, Sodium Lauroyl lactylate, Glycerin, PEG-100 Stearate, Glyceryl Stearate, Juglans Regia (Walnut) Shell Powder, Cetyl Alcohol, Ceteareth-20, Polysorbate 60, Titanium Dioxide UF, Hydrolyzed Wheat Protein, Mentha Piperita (Peppermint) leaf water, Sodium Polyacrylate Acrylamide Copolymer, Trideceth-6, Caprylhydroxamic Acid, Phenoxyethanol, Methylpropanediol, Fragrance 

Questions or comments?

Call 1-305-622-7474 Monday through Friday 9:00 AM to 5:00 PM

PACKAGE LABEL

170 g in Tube (NDC: 74553-006-01)

INGREDIENTS AND APPEARANCE

OKAY NOURISHING PEPPERMINT SCRUB AND MASK 
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74553-006
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
WATER (UNII: 059QF0KO0R)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-100 STEARATE (UNII: YD01N1999R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
JUGLANS REGIA SHELL (UNII: PJ10MT7VKA)
CETYL ALCOHOL (UNII: 936JST6JCN)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
POLYSORBATE 60 (UNII: CAL22UVI4M)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
HYDROLYZED WHEAT PROTEIN (ENZYMATIC; 3000 MW) (UNII: J2S07SB0YL)
PEPPERMINT OIL (UNII: AV092KU4JH)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
ACRYLAMIDE (UNII: 20R035KLCI)
TRIDECETH-6 (UNII: 3T5PCR2H0C)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74553-006-01	170 g in 1 TUBE; Type 0: Not a Combination Product	04/21/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	04/21/2021

Labeler - Xtreme Tools International, Inc (125398904)

Registrant - Xtreme Tools International, Inc (125398904)

Establishment
Name	Address	ID/FEI	Business Operations
Xtreme Tools International, Inc		125398904	manufacture(74553-006)