Rejuvaderm MediSpa Acne Back

Manufacturer
Ellen Frankle MD Inc.
Effective date
2010-07-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:25:45

Label at a glance#

ProductRejuvaderm MediSpa Acne Back
Active ingredientSALICYLIC ACID
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION


Active Ingredients                  Purpose

Salicylic acid 2.0%                  Acne Treatment

INDICATIONS & USAGE SECTION


Use For the treatment of acne.

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

WARNINGS SECTION


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 SECTION


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 SECTION


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

OTC - PURPOSE SECTION


Acne treatment

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1048903salicylic acid 2 % Topical SprayPSN1
1048903salicylic acid 20 MG/ML Topical SpraySCD1
1048903salicylic acid 2 % Topical SpraySY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51325-400-042019-10-21C16284748780-1956f9ecf-c4f8-621f-e053-dbdaa90a74adRejuvaderm Medispa Acne back

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51325-400-04Rejuvaderm MediSpa Acne Back240 mL in 1 BOTTLESPRAY2401
51325-400-04Rejuvaderm MediSpa Acne Back1 in 1 BOXSPRAY11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51325-400REJUVADERM MEDISPA ACNE BACK (SALICYLIC ACID) SPRAY [ELLEN FRANKLE MD INC.]1Legacy NDC, 2 package rows20100907_dec5ef2e-2e62-4093-83a1-56300d1f182e.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
SALICYLIC ACIDACTIVE INGREDIENTO414PZ4LPZ1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZ1
Benzalkonium chlorideINACTIVE INGREDIENTF5UM2KM3W71
Isopropyl alcoholINACTIVE INGREDIENTND2M4163021
Polysorbate 20INACTIVE INGREDIENT7T1F30V5YH1
WaterINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51325-40051325-400-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 61 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Polysorbate 20POLYSORBATE 207T1F30V5YHTAMPON / VAGINAL64.8 mgExact identifier — unii candidate
28 equally ranked IID candidates
Polysorbate 20POLYSORBATE 207T1F30V5YHSOAP / TOPICAL0.02 %w/wExact identifier — unii candidate
28 equally ranked IID candidates
Polysorbate 20POLYSORBATE 207T1F30V5YHINJECTION, SOLUTION / SUBCUTANEOUSNAExact identifier — unii candidate
28 equally ranked IID candidates
Benzalkonium chlorideBENZALKONIUM CHLORIDEF5UM2KM3W7INJECTION / INTRAMUSCULAR1 mgExact identifier — unii candidate
24 equally ranked IID candidates
Polysorbate 20POLYSORBATE 207T1F30V5YHINJECTION / INTRAMUSCULAR1.62 %w/vExact identifier — unii candidate
28 equally ranked IID candidates
Benzalkonium chlorideBENZALKONIUM CHLORIDEF5UM2KM3W7LIQUID / NASAL0.2 mg/1mlExact identifier — unii candidate
24 equally ranked IID candidates
Benzalkonium chlorideBENZALKONIUM CHLORIDEF5UM2KM3W7GEL / OPHTHALMIC0.01 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
Polysorbate 20POLYSORBATE 207T1F30V5YHSUSPENSION / AURICULAR (OTIC)0.1 %w/vExact identifier — unii candidate
28 equally ranked IID candidates
Polysorbate 20POLYSORBATE 207T1F30V5YHEMULSION / TOPICAL2 %w/wExact identifier — unii candidate
28 equally ranked IID candidates
Benzalkonium chlorideBENZALKONIUM CHLORIDEF5UM2KM3W7SUSPENSION/ DROPS / AURICULAR (OTIC)0.02 %w/vExact identifier — unii candidate
24 equally ranked IID candidates
Polysorbate 20POLYSORBATE 207T1F30V5YHSUPPOSITORY / VAGINALNAExact identifier — unii candidate
28 equally ranked IID candidates
Isopropyl alcoholISOPROPYL ALCOHOLND2M416302GEL, METERED / TOPICAL525 mgExact identifier — unii candidate
9 equally ranked IID candidates
Polysorbate 20POLYSORBATE 207T1F30V5YHINJECTION / INTRAVENOUS30 mgExact identifier — unii candidate
28 equally ranked IID candidates
Benzalkonium chlorideBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION / TOPICAL0.02 %w/vExact identifier — unii candidate
24 equally ranked IID candidates
Isopropyl alcoholISOPROPYL ALCOHOLND2M416302SWAB / TOPICAL43.9 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
Polysorbate 20POLYSORBATE 207T1F30V5YHPOWDER, FOR SUSPENSION / ORAL1.3 mg/5mlExact identifier — unii candidate
28 equally ranked IID candidates
Polysorbate 20POLYSORBATE 207T1F30V5YHCLOTH / TOPICALNAExact identifier — unii candidate
28 equally ranked IID candidates
Polysorbate 20POLYSORBATE 207T1F30V5YHSUSPENSION / OPHTHALMIC0.05 %w/vExact identifier — unii candidate
28 equally ranked IID candidates
Polysorbate 20POLYSORBATE 207T1F30V5YHSUSPENSION / ORAL80 mgExact identifier — unii candidate
28 equally ranked IID candidates
Isopropyl alcoholISOPROPYL ALCOHOLND2M416302OIL / TOPICAL72 mgExact identifier — unii candidate
9 equally ranked IID candidates
Polysorbate 20POLYSORBATE 207T1F30V5YHSPRAY, METERED / NASAL40 mgExact identifier — unii candidate
28 equally ranked IID candidates
Polysorbate 20POLYSORBATE 207T1F30V5YHTABLET, EXTENDED RELEASE / ORAL4.2 mgExact identifier — unii candidate
28 equally ranked IID candidates
Polysorbate 20POLYSORBATE 207T1F30V5YHINJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR60 mgExact identifier — unii candidate
28 equally ranked IID candidates
Isopropyl alcoholISOPROPYL ALCOHOLND2M416302TABLET, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
9 equally ranked IID candidates
Benzalkonium chlorideBENZALKONIUM CHLORIDEF5UM2KM3W7LOTION / TOPICAL0.1 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
Polysorbate 20POLYSORBATE 207T1F30V5YHINJECTION / SUBCUTANEOUSNAExact identifier — unii candidate
28 equally ranked IID candidates
Polysorbate 20POLYSORBATE 207T1F30V5YHSOLUTION / TOPICAL15 %w/wExact identifier — unii candidate
28 equally ranked IID candidates
Isopropyl alcoholISOPROPYL ALCOHOLND2M416302OIL / AURICULAR (OTIC)6 mgExact identifier — unii candidate
9 equally ranked IID candidates
Benzalkonium chlorideBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION/ DROPS / AURICULAR (OTIC)0 %w/vExact identifier — unii candidate
24 equally ranked IID candidates
Polysorbate 20POLYSORBATE 207T1F30V5YHAEROSOL, FOAM / VAGINAL3 %w/wExact identifier — unii candidate
28 equally ranked IID candidates
Benzalkonium chlorideBENZALKONIUM CHLORIDEF5UM2KM3W7OINTMENT / TOPICAL0.03 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
Benzalkonium chlorideBENZALKONIUM CHLORIDEF5UM2KM3W7SUSPENSION / AURICULAR (OTIC)0.01 %w/vExact identifier — unii candidate
24 equally ranked IID candidates
Benzalkonium chlorideBENZALKONIUM CHLORIDEF5UM2KM3W7SPRAY, METERED / NASAL1 mgExact identifier — unii candidate
24 equally ranked IID candidates
Benzalkonium chlorideBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION / RESPIRATORY (INHALATION)0.02 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
Benzalkonium chlorideBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION / OPHTHALMIC2 %w/vExact identifier — unii candidate
24 equally ranked IID candidates
Benzalkonium chlorideBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION / NASAL40.46 mg/100mlExact identifier — unii candidate
24 equally ranked IID candidates
Benzalkonium chlorideBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION / AURICULAR (OTIC)0.01 %w/vExact identifier — unii candidate
24 equally ranked IID candidates
Polysorbate 20POLYSORBATE 207T1F30V5YHINJECTION, SOLUTION / INTRAVENOUS30 mgExact identifier — unii candidate
28 equally ranked IID candidates
Isopropyl alcoholISOPROPYL ALCOHOLND2M416302LOTION, AUGMENTED / TOPICAL2070 mgExact identifier — unii candidate
9 equally ranked IID candidates
Benzalkonium chlorideBENZALKONIUM CHLORIDEF5UM2KM3W7SHAMPOO / TOPICAL0.2 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
Polysorbate 20POLYSORBATE 207T1F30V5YHCREAM / TOPICAL108 mgExact identifier — unii candidate
28 equally ranked IID candidates
Benzalkonium chlorideBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION/ DROPS / TOPICAL0.01 %w/vExact identifier — unii candidate
24 equally ranked IID candidates
Polysorbate 20POLYSORBATE 207T1F30V5YHGEL / TOPICAL5 %w/wExact identifier — unii candidate
28 equally ranked IID candidates
Polysorbate 20POLYSORBATE 207T1F30V5YHSHAMPOO / TOPICAL8 %w/wExact identifier — unii candidate
28 equally ranked IID candidates
Isopropyl alcoholISOPROPYL ALCOHOLND2M416302GEL / TOPICAL75 mgExact identifier — unii candidate
9 equally ranked IID candidates
Benzalkonium chlorideBENZALKONIUM CHLORIDEF5UM2KM3W7SPRAY / NASAL1 mgExact identifier — unii candidate
24 equally ranked IID candidates
Polysorbate 20POLYSORBATE 207T1F30V5YHINJECTION, POWDER, FOR SOLUTION / INTRAVENOUSNAExact identifier — unii candidate
28 equally ranked IID candidates
Polysorbate 20POLYSORBATE 207T1F30V5YHLOTION / TOPICAL2000 mgExact identifier — unii candidate
28 equally ranked IID candidates
Benzalkonium chlorideBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION/ DROPS / OPHTHALMIC1 mgExact identifier — unii candidate
24 equally ranked IID candidates
Benzalkonium chlorideBENZALKONIUM CHLORIDEF5UM2KM3W7SUSPENSION/ DROPS / OPHTHALMIC0.02 %w/vExact identifier — unii candidate
24 equally ranked IID candidates
Isopropyl alcoholISOPROPYL ALCOHOLND2M416302SPONGE / TOPICAL4 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
Polysorbate 20POLYSORBATE 207T1F30V5YHAEROSOL, FOAM / TOPICAL3.7 %w/wExact identifier — unii candidate
28 equally ranked IID candidates
Benzalkonium chlorideBENZALKONIUM CHLORIDEF5UM2KM3W7SUSPENSION/ DROPS / TOPICALNAExact identifier — unii candidate
24 equally ranked IID candidates
Benzalkonium chlorideBENZALKONIUM CHLORIDEF5UM2KM3W7INJECTION / INTRA-ARTICULAR1 mgExact identifier — unii candidate
24 equally ranked IID candidates
Isopropyl alcoholISOPROPYL ALCOHOLND2M416302SOLUTION / TOPICAL40 %w/vExact identifier — unii candidate
9 equally ranked IID candidates
Polysorbate 20POLYSORBATE 207T1F30V5YHCAPSULE / ORAL563 mgExact identifier — unii candidate
28 equally ranked IID candidates
Polysorbate 20POLYSORBATE 207T1F30V5YHTABLET, FILM COATED / ORAL0.35 mgExact identifier — unii candidate
28 equally ranked IID candidates
Polysorbate 20POLYSORBATE 207T1F30V5YHTABLET / ORAL17 mgExact identifier — unii candidate
28 equally ranked IID candidates
Benzalkonium chlorideBENZALKONIUM CHLORIDEF5UM2KM3W7CLOTH / TOPICALNAExact identifier — unii candidate
24 equally ranked IID candidates
Benzalkonium chlorideBENZALKONIUM CHLORIDEF5UM2KM3W7INJECTION / INTRALESIONAL1 mgExact identifier — unii candidate
24 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
6f861083-6259-47ff-b8b9-6c74f32dd10cdec5ef2e-2e62-4093-83a1-56300d1f182e2010-07-20WarningsExact identifier
spl id: 6f861083-6259-47ff-b8b9-6c74f32dd10c
spl set id: dec5ef2e-2e62-4093-83a1-56300d1f182e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.