OKAY FACIAL SERUM- salicylic acid gel

OKAY Facial Serum by

Drug Labeling and Warnings

OKAY Facial Serum by is a Otc medication manufactured, distributed, or labeled by Xtreme Tools International, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Salicylic Acid (2%)

Purpose

Acne Treatment

Use

For the treatment of acne.

Warning

For External use only

When using this product

■ skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical medication at a time. Avoid contact with eyes. If contact occurs, flush thoroughly with water.

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

■ clean the skin thoroughly before applying this product

■ cover the entire affected area with a thin layer one to three times daily

■ because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor

■ if bothersome dryness or peeling occurs, reduce application to once a day or every other day

Inactive Ingredients

Water (Aqua), Propanediol, Xylitylglucoside, Anhydroxylitol, Xylitol, C15-19 Alkane (Natural), Caprylyl/Capryl Glucoside, Polyacrylate Crosspolymer-6, Sodium Hydroxide, Carica Papaya (Papaya) Fruit Extract, Psidium Guajava Fruit Extract, Phenoxyethanol, Ethylhexylglycerin.

QUESTIONS

Questions or comments?
Call 1-305-622-7474 Mon-Fri 9 am-5 pm

PACKAGE LABEL

NDC: 74553-014-01

INGREDIENTS AND APPEARANCE

OKAY FACIAL SERUM 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74553-014
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 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPANEDIOL (UNII: 5965N8W85T)
XYLITYLGLUCOSIDE (UNII: O0IEZ166FB)
ANHYDROXYLITOL (UNII: 8XWR7NN42F)
XYLITOL (UNII: VCQ006KQ1E)
C15-19 ALKANE (UNII: CI87N1IM01)
CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)
AMMONIUM ACRYLOYLDIMETHYLTAURATE (UNII: KBC00G95HI)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PAPAYA (UNII: KU94FIY6JB)
GUAVA (UNII: 74O70D6VG0)
Phenoxyethanol (UNII: HIE492ZZ3T)
Ethylhexylglycerin (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74553-014-01	1 in 1 BOX	09/11/2023
1		30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M006	09/11/2023

Labeler - Xtreme Tools International, Inc (125398904)