REJUVADERM MEDISPA ACNE BACK- salicylic acid spray

Rejuvaderm MediSpa Acne Back by

Drug Labeling and Warnings

Rejuvaderm MediSpa Acne Back by is a Otc medication manufactured, distributed, or labeled by Ellen Frankle MD Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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).

PURPOSE

Acne treatment

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.

PRINCIPAL DISPLAY PANEL

Rejuvaderm Medispa

reawaken the essence that is you

acne back spray

8 fl oz. (240 ml)

401944skin

www.riskindoc.com

www.rejuvadermmedispa.com

INGREDIENTS AND APPEARANCE

REJUVADERM MEDISPA ACNE BACK  
salicylic acid spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51325-400
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	4.8 mL  in 240 mL

Inactive Ingredients
Ingredient Name	Strength
Benzalkonium chloride (UNII: F5UM2KM3W7)
Isopropyl alcohol (UNII: ND2M416302)
Polysorbate 20 (UNII: 7T1F30V5YH)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51325-400-04	1 in 1 BOX
1		240 mL in 1 BOTTLE

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)