ACTIOGEN ACNE DOTS TREATMENT- acne treatment patch 
Actiogen 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.

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Actiogen Acne Dots

Active Ingredients

Salicylic Acid 2%

Purpose

Acne Treatment

Use

For the treatment of acne

Warnings

For external use only

When Using This Product

Using other topical acne medication at the same time or immediately following use of this product may increase dryness or irritation of the skin.  If this occurs, only one medication should be used unless directed by a doctor

Stop Using This Product 

Discontinue use if you notice an redness, burning, or other forms of irritation

Do Not Use

Do not use on broken skin or open wounds

Consult a physician

Consult your physician in case of adverse reaction

Keep Out of Reach of Children

Keep away from children

Other Information

Store in a cool dry place.

Inactive Ingredients

Acrylic adhesive, kollidon, 1,2 Propylene Glycol, Zinc Oxide

Front of box

Front of Box

Back of Box

ACTIOGEN ACNE DOTS TREATMENT 
acne treatment patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69186-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 mg  in 100 mg
Inactive Ingredients
Ingredient NameStrength
ACRYLIC ACID (UNII: J94PBK7X8S) 96 mg  in 100 mg
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 1 mg  in 100 mg
ZINC OXIDE (UNII: SOI2LOH54Z) 1 mg  in 100 mg
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69186-001-1010 in 1 BOX08/01/2014
12 mg in 1 PACKAGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D08/01/2014
Labeler - Actiogen Corp (967358057)

Revised: 7/2015
Document Id: ba32c96a-bd18-4b8c-bca8-c31aad906f5a
Set id: f07fbee0-cab6-42fa-a11a-f6e3031688e1
Version: 2
Effective Time: 20150714
 
Actiogen Corp