OTC Medication Information: ACNE CLEANSER

ACNE CLEANSER- salicylic acid gel
MONAT GLOBAL CORP

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.

Active Ingredient

Salicylic Acid 2.00%

Purpose

Acne Treatment

Uses

  • For the treatment of acne
  • Helps prevent new acne blemishes from forming

For external use only

When using this product

  • skin irritation and dryness are more likely to occur if you use another topicalk acne medication at the same time. If irriatation occurs, only use one topical acne treatment at a time.
  • Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Keep out of reach of children. If product is swallowed, get medical help or contact a poison control center right immediately.

Directions

Directions

  • Shake well before use
  • Start with damp skin
  • Apply small amount onto your fingertips and emulsify
  • Gently cleanse the skin using circular motions.
  • Rinse with warm water and gently pat the skin dry
  • Follow with your MONAT skincare Routine

Inactive Ingredients

Water, Sodium Cocoyl Glutamate, Propanediol, Sorbeth-230 Tetraoleate, Cocamidopropyl Betaine, Sodium C14-16 Olefin Sulfonate, Sodium Cocoyl Isethionate, PEG-120 Methyl Glucose Dioleate, Niacinamide, Cocamide MIPA, Glycerin, Coconut Acid, Sodium Isethionate, Sodium PCA, Maclura Cochinchinensis Leaf Prenylflavonoids, Glycol Distearate, Laureth-4, Sodium Chloride, Sodium Benzoate, Potassium Sorbate, Polyquaternium-10, Decyl Glucoside, Sorbitan Laurate, Isopropyl Alcohol.

Questions or Comments

Questions or comments?

Toll-free number 1-800-878-1978

PRIMARY PACKAGE

Primary Package
(click image for full-size original)

OUTER PACKAGE

Outer package
(click image for full-size original)

ACNE CLEANSER
salycilic acid gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:78518-011
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 2 mg in 100 mg
Inactive Ingredients
Ingredient Name Strength
LAURETH-4
SODIUM ISETHIONATE
GLYCERIN
WATER
SODIUM COCOYL GLUTAMATE
PROPANEDIOL
GLYCOL DISTEARATE
DECYL GLUCOSIDE, .ALPHA.-
SODIUM PYRROLIDONE CARBOXYLATE
COCONUT ACID
NIACINAMIDE
SODIUM COCOYL ISETHIONATE
SODIUM C14-16 OLEFIN SULFONATE
COCAMIDOPROPYL BETAINE
POLYQUATERNIUM-10 (400 CPS AT 2%)
SODIUM CHLORIDE
MACLURA COCHINCHINENSIS WHOLE
ISOPROPYL ALCOHOL
SORBITAN MONOLAURATE
POTASSIUM SORBATE
SODIUM BENZOATE
COCO MONOISOPROPANOLAMIDE
PEG-120 METHYL GLUCOSE DIOLEATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:78518-011-01 1 TUBE in 1 CARTON contains a TUBE
1 120 mg in 1 TUBE This package is contained within the CARTON (78518-011-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final M006 04/04/2023
Labeler — MONAT GLOBAL CORP (027036949)
Establishment
Name Address ID/FEI Operations
Oxygen Development 137098492 manufacture (78518-011)

Revised: 03/2023 MONAT GLOBAL CORP

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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