MD ACNE CUSTOMIZED TREATMENT- salicylic acid cream 
MDalgorithms 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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MD ACNE Customized Treatment Cream

DRUG FACTS:

Active Ingredient:

Salicylic Acid 2.00%

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:

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.

Store at room temperature

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.

Other Ingredients:

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Baebadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Ascorbic Acid (Vitamin C), Butylene Glycol, Camellia Sinensis (Green Tea) Extract, Cucumis Sativus (Cucumber) Fruit Extract, Ethylhexylglycerin, Glycerin, Glycyrrhiza Glabra (Licorice) Root Extract, Hamamelis Virginiana (witch Hazel), Melaleuca Alternifolia (Tea Tree) Leaf Oil, Parfum (Fragrance), Phenoxyethanol, Polysorbate-20, SD-Alcohol 40B, Sodium PCA, Tocopheryl Acetate (Vitamin E), Triethanolamine.

Package Labeling:

Label5

MD ACNE CUSTOMIZED TREATMENT 
salicylic acid cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:71804-854
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
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CUCUMBER (UNII: YY7C30VXJT)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
TEA TREE OIL (UNII: VIF565UC2G)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:71804-854-00 90 mL in 1 TUBE; Type 0: Not a Combination Product 10/12/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333D 10/12/2017
Labeler - MDalgorithms Inc (080479826)

Revised: 10/2017
Document Id: 5b5a74a5-b53a-0776-e053-2991aa0ab5b2
Set id: 07cb4ee6-b9ac-43d0-aa1a-10ca26502046
Version: 1
Effective Time: 20171012
 
MDalgorithms Inc