FDA.reportPublic FDA data

Nativae Milia Acne Serum

Manufacturer
CDE BRANDS LLC
Effective date
2024-12-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:49:20

Label at a glance#

ProductNativae Milia Acne Serum
Active ingredientSALICYLIC ACID
Label structure8 sections

Indications and uses

For the treatment of acne. Penetrates pores to clear most acne blemishes Helps keep skin clear of new acne pimples, blackheads, or whiteheads

Dosage and administration

Wet the skin and apply the medication to the areas to be cleansed. cover the entire affected area with a thin layer one to three times daily. Massage gently into the skin working it into a full lather. Rinse thoroughly with plain water. Pat the skin dry. because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by ...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 2.0%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Uses

INDICATIONS & USAGE SECTION

  • For the treatment of acne.
  • Penetrates pores to clear most acne blemishes
  • Helps keep skin clear of new acne pimples, blackheads, or whiteheads

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same or immediately following use of this product. If this occurs, use only one topical acne medication at a time.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation becomes severe.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help, or contact a Poison Control Center right away.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use

Directions

DOSAGE & ADMINISTRATION SECTION

  • Wet the skin and apply the medication to the areas to be cleansed. cover the entire affected area with a thin layer one to three times daily. Massage gently into the skin working it into a full lather. Rinse thoroughly with plain water. Pat the skin dry.
  • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
  • if bothersome dryness or peeling occurs, reduce application to once a day or every other day.
  • if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor

Other information

SPL UNCLASSIFIED SECTION

  • Protect the product in this container from excessive heat and direct sun.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice, Cetearyl Olivate, Ethylhexylglycerin, Eucalyptus Globulus Leaf Oil, Glycerin, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Phenoxyethanol, Sodium Hydroxide, Sorbitan Olivate, Water (Aqua), Xanthan Gum

Questions?

OTC - QUESTIONS SECTION

(888) 233-2239

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label0Label0

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
346298salicylic acid 2 % Topical GelPSN1
346298salicylic acid 0.02 MG/MG Topical GelSCD1
346298salicylic acid 2 % Topical GelSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85065-557-00Nativae Milia Acne Serum30 mL in 1 BOTTLELIQUID301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85065-557NATIVAE MILIA ACNE SERUM (SALICYLIC ACID) LIQUID [CDE BRANDS LLC]1Current NDC, 1 package rows20241228_e04cf0a2-bda7-4e5b-9771-769995cf6925.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85065-55785065-557-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
CETEARYL OLIVATE58B69Q84JOIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
EUCALYPTUS OIL2R04ONI662IACT
GLYCERINPDC6A3C0OXIACT
TEA TREE OILVIF565UC2GIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SODIUM HYDROXIDE55X04QC32IIACT
SORBITAN OLIVATEMDL271E3GRIACT
WATER059QF0KO0RIACT
XANTHAN GUMTTV12P4NEEIACT
SALICYLIC ACIDO414PZ4LPZACTIB

Source Document#

Source XML

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
Nativae Milia Acne SerumSALICYLIC ACIDCDE BRANDS LLCe04cf0a2-bda7-4e5b-9771-769995cf69252024-12-26WarningsExact identifier
ndc (package): 85065-557-00
ndc (product): 85065-557
ndc11 (package): 85065055700
spl id: 2a2e9c4d-6091-2331-e063-6294a90aa2f8
spl set id: e04cf0a2-bda7-4e5b-9771-769995cf6925

Reported adverse events (FAERS/openFDA)#

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