Your browser does not support JavaScript! ASEPXIA (SALICYLIC ACID) LOTION [TELEVISA CONSUMER PRODUCTS USA]
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ASEPXIA (salicylic acid) lotion
[Televisa Consumer Products USA]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

Active Ingredients

Salicylic Acid 1.86%

Purpose

Acne Treatment

Uses

  • for the treatment of acne
  • clears up acne blemishes, acne pimples, blackheads, whiteheads and allows skin to heal
  • helps prevent new acne blemishes, acne pimples, blackheads or whiteheads from forming.

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.

  • cover the entire affected area with a thin layer one to three times daily.
  • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.
  • if both some dryness or peeling occurs, reduce application to once a day or every other day.
  • Sensitivity Test for a New User:  Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above.

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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:55038-555
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID18.6 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE 
BENZOIC ACID 
CAMPHOR (SYNTHETIC) 
CLOVE OIL 
ALCOHOL 
EUCALYPTUS OIL 
PEPPERMINT OIL 
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55038-555-01120 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D08/17/2011
Labeler - Televisa Consumer Products USA (840246230)
Registrant - Laboratorios Kener, S.A. de C.V. (810347658)
Establishment
NameAddressID/FEIBusiness Operations
Laboratorios Kener, S.A. de C.V.810347658manufacture(55038-555)

Revised: 4/2013
 
Televisa Consumer Products USA

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