Acne Treatment Gel
FDA Label NDC 67234-007

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Natureplex, Llc for the product Acne Treatment (NDC 67234-007). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, use, warnings, when using this product, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

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.

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

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)

Principal Display Panel (42.5 g Tube Box)

Principal Display Panel (42.5 g Tube Box)

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