ASEPXIA  - salicylic acid lotion 
Televisa Consumer Products USA

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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Asepxia Lotion

Active Ingredients

Salicylic Acid 1.86%

Purpose

Acne Treatment

Uses

Warnings


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 he same time. If irritation occurs, only use one topical acne medication at a time.

Keep out of the reach of children.

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

Directions

Clean the skin thoroughly before applying this product.

Inactive Ingredients

benzalkonium chloride, benzoic acid, camphor, clove oil, ethyl alcohol, eucalyptus oil, peppermint oil, water.

Questions or Comments?

1 877 99 GENOM  
               (43666)

Made in Mexico

Distributed by:
Televisa Consumer Products USA, LLC
4550 Post Oak Place Suite 326
Houston, TX 77027

Asepxia

Acne Lotion

For the treatment of Acne

Eliminates most pimples and blackheads

Net Wt 4fl oz (120mL)

Outer Container Label

Asepxia

Container Label

Asepxia

ASEPXIA  
salicylic acid lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55038-555
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 18.6 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
CLOVE OIL (UNII: 578389D6D0)  
ALCOHOL (UNII: 3K9958V90M)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
WATER (UNII: 059QF0KO0R)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55038-555-01 120 mL in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333D 08/17/2011
Labeler - Televisa Consumer Products USA (840246230)
Registrant - Laboratorios Kener, S.A. de C.V. (810347658)
Establishment
Name Address ID/FEI Business Operations
Laboratorios Kener, S.A. de C.V. 810347658 manufacture(55038-555)

Revised: 4/2013
Document Id: 6501d8ea-99a9-48e2-86f9-28f2ac43c748
Set id: c118dc78-7d4b-492c-b0be-078f69e3909b
Version: 4
Effective Time: 20130425
 
Televisa Consumer Products USA