SALICYLIC ACID ACNE TREATMENT- salicylic acid soap

Salicylic Acid Acne Treatment by

Drug Labeling and Warnings

Salicylic Acid Acne Treatment 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

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

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

PACKAGE LABEL

NDC 74553-012-01 

INGREDIENTS AND APPEARANCE

SALICYLIC ACID ACNE TREATMENT 
salicylic acid soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74553-012
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
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74553-012-01	255 g in 1 BOX; Type 0: Not a Combination Product	09/11/2023

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)