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Acne Treatment by Natureplex LLC

Dosage form: gel
Ingredients: SALICYLIC ACID 0.005mg in 1g
Labeler: Natureplex LLC
NDC Code: 67234-007

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.

Acne Treatment

Drug Facts

Active ingredient

Salicylic Acid 0.5%

Purpose

Acne Treatment

Use

For the treatment of acne.

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.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

Directions
  • 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 below
  • clean the skin thoroughly before applying this product
  • cover entire affected area with a thin layer 1 to 3 times daily
  • because excessive drying of skin may occur, start with one application daily, and 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

Other information
  • store at 15 to 30°C (59 to 86°F)
  • close cap tightly after use
  • Tamper Evident: DO NOT USE IF SEAL ON TUBE IS BROKEN OR MISSING.

Inactive ingredients

citric acid, sodium phosphate dibasic, DMDM hydantoin, glycerin, hydroxyethylcellulose, isopropyl alcohol, methylparaben, polysorbate-20, propylene glycol, propylparaben, purified water

Questions or comments?

866-323-0107 or www.natureplex.com

PRINCIPAL DISPLAY PANEL - 42.5 g Tube Box

Natureplex

Acne
Treatment
Clear Gel

NET WT. 1.5 Oz.(42.5g)

ACNE TREATMENT 
salicylic acid gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67234-007
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID0.005 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
DMDM HYDANTOIN 
GLYCERIN 
HYDROXYETHYL CELLULOSE (1500 MPA.S AT 1%) 
METHYLPARABEN 
PROPYLPARABEN 
PROPYLENE GLYCOL 
WATER 
Packaging
#Item CodePackage Description
1NDC:67234-007-011 TUBE in 1 BOX
142 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D01/02/2007
Labeler - Natureplex LLC (062808196)
Establishment
NameAddressID/FEIOperations
Natureplex LLC062808196MANUFACTURE(67234-007)

Revised: 11/2017
 
Natureplex LLC

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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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