Rejuvaderm Medispa Acne Back
FDA Label NDC 51325-400

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Ellen Frankle Md Inc. for the product Rejuvaderm Medispa Acne Back (NDC 51325-400). 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 otc - active ingredient, indications & usage, warnings, dosage & administration, inactive ingredient, otc - purpose, otc - keep out of reach of children, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient



Active Ingredients                  Purpose

Salicylic acid 2.0%                  Acne Treatment

Indications & Usage



Use For the treatment of acne.

  • penetrates pores to control acne blemishes.
  • helps keep skin clear of new acne blemishes.

Warnings



Warnings

For external use only

When using this product

  • with other topical acne medication at the same time or immediately following the use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor. avoid contact with eyes. If eye contact occurs, rinse thoroughly with water. apply to affected area only. do not use on broken skin. do not aply to large areas of the body. Spray in a well ventilated area. Do not inhale.
  • flammable-keep away from open fire or flame.

    Stop use and ask a doctor if
  • rash or irritation develops and lasts.
    • Sunburn Alert: this product may increase your skin's sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing and limit sun exposure while using this product and for one week afterwards.

Dosage & Administration



Directions

  • Apply byspraying directly onto back.
  • Pump works upside down to secure application.
  • Let dry prior to dressing.
  • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Inactive Ingredient



Inactive Ingredients Benzalkonium Chloride, Isopropyl Alcohol, Polysorbate 20, Water (Aqua).

Otc - Purpose



Acne treatment

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Package Label.Principal Display Panel

Label (Backspraylabel)

Label (Backspraylabel)


Rejuvaderm Medispa

reawaken the essence that is you

acne back spray

8 fl oz. (240 ml)

401944skin

www.riskindoc.com

www.rejuvadermmedispa.com

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