MDACNE CUSTOMIZED ACNE TREATMENT SALICYLIC ACID- salicylic acid cream

MDacne Customized Acne Treatment Salicylic Acid by

Drug Labeling and Warnings

MDacne Customized Acne Treatment Salicylic Acid by is a Otc medication manufactured, distributed, or labeled by MDAlgorithms Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS:

Active Ingredient:

Salicylic Acid 2.0%

Purpose

Acne Treatment

Use For:

For the treatment of Acne. Clears up acne pimples and blemishes, and allows skin to heal. Helps prevent new pimples and blemishes from forming.

Warnings:

For external use only.

• Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin.
• Because excessive drying of the skin may occur, start with one use daily. Gradually increase to two times daily if needed or as directed by a doctor. If bothersome dryness or peeling occurs, reduce application to once per day.

  Do not use 

for prolonged periods without consulting a doctor.

Keep out of reach of children.

If swallowed, contact physician or poison control center immediately.

Directions:

Cleanse the skin thoroughly before applying medication. Apply even layer over affected area. Do not use on broken skin or large parts of the body. *For best results apply one to three times per day.

Other information:

Store in a cool, dry place below 20ºC (70ºF).

Inactive Ingredients:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Ascorbic Acid (Vitamin C), C12 15 Alkyl Benzoate, Camellia Sinensis (Green Tea) Extract, Cetearyl Alcohol, Cucumis Sativus (Cucumber) Fruit Extract, Dimethicone, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Glyceryl Stearate SE, Glycyrrhiza Glabra (Licorice) Root Extract, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Lavandula Angustifolia (Lavender) Oil, Magnesium Aluminum Silicate, PEG 100 Stearate, Phenoxyethanol, Polysorbate 80, Propylene Glycol, Tetrasodium EDTA, Tocopheryl Acetate (Vitamin E), Zemea (Corn) Propanediol.

Questions:

Contact us at support@mdacne.com

Package Labelling:

INGREDIENTS AND APPEARANCE

MDACNE CUSTOMIZED ACNE TREATMENT SALICYLIC ACID 
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71804-533
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CUCUMBER (UNII: YY7C30VXJT)
DIMETHICONE, UNSPECIFIED (UNII: 92RU3N3Y1O)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
LAVENDER OIL (UNII: ZBP1YXW0H8)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
PEG-100 STEARATE (UNII: YD01N1999R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
EDETATE SODIUM (UNII: MP1J8420LU)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CORN (UNII: 0N8672707O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71804-533-00	1 in 1 BOX	09/12/2024
1		15 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	09/12/2024

Labeler - MDAlgorithms Inc (080479826)