OKAY BODY WASH- salicylic acid gel 
Xtreme Tools International, Inc

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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OKAY Body Wash- SALICYLIC ACID ACNE MEDICATION

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

Directions

Wet body. Massage over body for a few minutes. Rinse. Recommended for daily use. Good for face, as well.

Inactive Ingredients

Water (Aqua), Sodium C14-16 Olefin Sulfonate, Cocamidopropyl Betaine, Decyl Glucoside, Glycerin, Acrylates Crosspolymer-4, Sodium Hydroxide, Carica Papaya (Papaya) Fruit Extract, Psidium Guajava (Guava) Fruit Extract, Panthenol, Synthetic Wax, Fragrance

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

Package Label

NDC 74553-018-01

Body Wash

OKAY BODY WASH 
salicylic acid gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74553-018
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Salicylic Acid (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) Salicylic Acid2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Sodium C14-16 Olefin Sulfonate (UNII: O9W3D3YF5U)  
Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
Decyl Glucoside (UNII: Z17H97EA6Y)  
Glycerin (UNII: PDC6A3C0OX)  
Acrylates Crosspolymer-4 (UNII: GEV2EL4D9G)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Papaya (UNII: KU94FIY6JB)  
Guava (UNII: 74O70D6VG0)  
Panthenol (UNII: WV9CM0O67Z)  
SYNTHETIC WAX (1800 MW) (UNII: 248P1AUJ90)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74553-018-01320 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/11/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM00609/11/2023
Labeler - Xtreme Tools International, Inc (125398904)

Revised: 9/2023
Document Id: e0e65340-45ce-4ffb-8468-d53a259c9159
Set id: 20cac579-d1a8-485c-9120-92a256161d07
Version: 1
Effective Time: 20230909
 
Xtreme Tools International, Inc