Label: REJUVADERM MEDISPA ACNE BACK- salicylic acid spray
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Contains inactivated NDC Code(s)
NDC Code(s): 51325-400-04 - Packager: Ellen Frankle MD Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated July 20, 2010
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
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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.
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
REJUVADERM MEDISPA ACNE BACK
salicylic acid sprayProduct 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)