SALICYLIC ACID ACNE TREATMENT- salicylic acid soap 
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 SOAP BAR- SALICYLIC ACID ACNE TREATMENT

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 face. Work soap into a lather with hands and gently massage onto skin. Rinse.

Inactive Ingredients

Sodium Palmate, Sodium Palm Kernelate, Sodium Cocoate, Water (Aqua), Glycerin, Cocos nucifera (Coconut)
Oil, Leptospermum Scoparium Branch/Leaf (Manuka) Oil, Limnanthes Alba (Meadowfoam) Seed Oil, Calendula Officinalis
Flower Extract, Aloe Barbadensis Leaf Extract, Allantoin, Tocopheryl Acetate, Tetrasodium Etidronate, Sodium Chloride, Fragrance.

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

PACKAGE LABEL

NDC 74553-012-01 

body-soap-bar

SALICYLIC ACID ACNE TREATMENT 
salicylic acid soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74553-012
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Salicylic Acid (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) Salicylic Acid2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SODIUM PALMATE (UNII: S0A6004K3Z)  
SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)  
SODIUM COCOATE (UNII: R1TQH25F4I)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
COCONUT OIL (UNII: Q9L0O73W7L)  
MANUKA OIL (UNII: M6QU9ZUH2X)  
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ALLANTOIN (UNII: 344S277G0Z)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ETIDRONATE TETRASODIUM (UNII: CZZ9T1T1X4)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74553-012-01255 g in 1 BOX; 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: 464741ff-9009-4bce-9f14-2f45cb5cdcb4
Set id: a95d6b12-03d8-44bc-b906-5b3beb4b3694
Version: 1
Effective Time: 20230907
 
Xtreme Tools International, Inc