Rejuvaderm MediSpa Acne Back: Package Insert and Label Information

REJUVADERM MEDISPA ACNE BACK — salicylic acid spray
Ellen Frankle MD Inc.

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.


Active Ingredients Purpose

Salicylic acid 2.0% Acne Treatment


Use For the treatment of acne.

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

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.

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


Acne treatment

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

label
(click image for full-size original)

Rejuvaderm Medispa

reawaken the essence that is you

acne back spray

8 fl oz. (240 ml)

401944skin

www.riskindoc.com

www.rejuvadermmedispa.com

REJUVADERM MEDISPA ACNE BACK
salicylic acid spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:51325-400
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 4.8 mL in 240 mL
Inactive Ingredients
Ingredient Name Strength
Benzalkonium chloride
Isopropyl alcohol
Polysorbate 20
Water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51325-400-04 1 BOTTLE (BOTTLE) in 1 BOX contains a BOTTLE
1 240 mL in 1 BOTTLE This package is contained within the BOX (51325-400-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333D 07/20/2010
Labeler — Ellen Frankle MD Inc. (603208240)

Revised: 07/2010 Ellen Frankle MD Inc.

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