ACNE CLEANSING- salicylic acid gel 
KitavaMD, 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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Salicylic Acid Acne Cleansing Gel

Drug Facts

Active Ingredient

Salicylic Acid 1%

Purpose

Acne Treatment

Use

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 acne medication at a time.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Inactive Ingredients

Disodium Cocoamphodiacetate, Water, Sodium Lauroyl Lactylate, Decyl Glucoside, Salix Nigra (Willow) Bark Extract, Phenoxyethanol, Melaleuca alternifolia (Tea Tree) Leaf Oil, Ethylhexylglycerin, Ascorbyl Palmitate, Glycerin, Camellia Sinensis (Green Tea) Leaf Extract

Package Labeling:

Label

ACNE CLEANSING 
salicylic acid gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72503-000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
WATER (UNII: 059QF0KO0R)  
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
TEA TREE OIL (UNII: VIF565UC2G)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
GLYCERIN (UNII: PDC6A3C0OX)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72503-000-00120 mL in 1 TUBE; Type 0: Not a Combination Product08/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D08/01/2018
Labeler - KitavaMD, Inc (074709983)

Revised: 10/2021
Document Id: cf47b461-fa14-7f33-e053-2a95a90ae2e1
Set id: d3ce64ac-c7e9-45aa-9a60-0b7c9e496d32
Version: 3
Effective Time: 20211026
 
KitavaMD, Inc