Medication Guide App

Salicylic Acne Pore Treatment

Dosage form: gel
Ingredients: SALICYLIC ACID .01mg in 1g
Labeler: CoValence Inc.
NDC Code: 66915-438

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.

Drug Facts

Active Ingredient

Salicylic Acid 1%


Purpose

Acne Medication

Keep out of reach of children.

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

Uses

  • for the treatment of acne
  • helps clear up acne blemishes
  • helps prevent new acne blemishes 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 the same time.  If irritation occurs, only use one topical acne medication at a time.
  • avoid contact with eyes.  If contact occurs, flush thoroughly with water.
  • do not use on broker or irritated skin

Stop use and ask a doctor if irritation become severe.


Directions

  • Clean skin thoroughly before applying this product. 
  • Cover the entire affected area with a thin layer 1 to 3 times daily.
  • Because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 or 3 times daily if needed or as directed by a doctor.
  • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.


Inactive Ingredients

Aqua (Water), Glycerin, C12-15 Alkyl Benzoate, Cyclopentasiloxane, Caprylic/Capric Triglyceride, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, >1, Biotin (D), Allantoin, Aloe Barbadensis Leaf Juice Powder*, Sodium Hyroxide, Phytic Acid, Xanthan Gum, Caprylyl Glycol, Phenoxyethanol

budhi Teencare acne prevention

SALICYLIC ACNE PORE TREATMENT 
salicylic acid gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66915-438
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID.01 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
GLYCERIN 
C12-15 ALKYL BENZOATE 
CYCLOMETHICONE 5 
MEDIUM-CHAIN TRIGLYCERIDES 
CARBOMER INTERPOLYMER TYPE A (55000 CPS) 
BIOTIN 
ALLANTOIN 
ALOE VERA LEAF 
SODIUM HYDROXIDE 
PHYTIC ACID 
XANTHAN GUM 
CAPRYLYL GLYCOL 
PHENOXYETHANOL 
Packaging
#Item CodePackage Description
1NDC:66915-438-021 TUBE (TUBE) in 1 BOX
1NDC:66915-438-0122.5 g in 1 TUBE
2NDC:66915-438-03200000 g in 1 DRUM
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D10/26/2010
Labeler - CoValence Inc. (070659375)
Establishment
NameAddressID/FEIOperations
CoValence Inc.070659375manufacture

Revised: 10/2010
 
CoValence Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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