FDA.reportPublic FDA data

Lavaderm After Sun

Manufacturer
Young Living Essential Oils, LC
Effective date
2024-09-16
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:19:38

Label at a glance#

ProductLavaderm After Sun For Pain and Itching
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure9 sections

Indications and uses

For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations

Dosage and administration

Shake Well Adults and children 2 years of age and older : apply to affected area not more than 3 to 4 times daily. Children under 2 years of age : ask a doctor

Storage and handling

store at controlled room temperature (68° to 77°F)

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 0.5%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

  • For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • avoid contact with eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children to avoid accidental ingestion. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Shake Well

Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • store at controlled room temperature (68° to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, olive oil, glycerin, safflower oil, sunflower oil, jojoba oil, polyglyceryl-10 pentastearate, glyceryl monocaprylate, helianthus annuus seed wax, European elderberry, xanthan gum, docosanol, sodium stearoyl lactylate, lavender oil, aloe vera leaf, glyceryl monoundecylenate, phytate sodium, picea mariana leaf oil, helichrysum italicum flower oil, citric add

Questions or comments?

OTC - QUESTIONS SECTION

call 1-800-371-3515

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FOR PAIN & ITCH

SOOTHES & COOLS SKIN

IMMEDIATE RELIEF

BoxBox

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1314935menthol 0.5 % Topical SprayPSN4
1314935menthol 5 MG/ML Topical SpraySCD4
1314935menthol 0.5 % Topical SpraySY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70631-034-252024-09-16C16284748780-10191ceaa-6be1-198a-e063-dbdaa90aec3eLavaderm After Sun
70631-034-252023-07-28C16284748780-10191ceaa-6be1-198a-e063-dbdaa90aec3eLavaderm After Sun

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70631-034-25Lavaderm After SunFor Pain and Itching1 in 1 BOXSPRAY14
70631-034-25Lavaderm After SunFor Pain and Itching57 g in 1 BOTTLE, SPRAYSPRAY574

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70631-034LAVADERM AFTER SUN FOR PAIN AND ITCHING (MENTHOL) SPRAY [YOUNG LIVING ESSENTIAL OILS, LC]4Legacy NDC, 2 package rows20240918_4c6e4fd7-3306-2936-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70631-03470631-034-25

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
DOCOSANOL9G1OE216XYIACT
XANTHAN GUMTTV12P4NEEIACT
PICEA MARIANA LEAF OILQ1J49L1A5OIACT
GLYCERYL MONOCAPRYLATETM2TZD4G4AIACT
WATER059QF0KO0RIACT
OLIVE OIL6UYK2W1W1EIACT
GLYCERINPDC6A3C0OXIACT
HELIANTHUS ANNUUS SEED WAX42DG15CHXVIACT
SAFFLOWER OIL65UEH262ISIACT
SUNFLOWER OIL3W1JG795YIIACT
JOJOBA OIL724GKU717MIACT
POLYGLYCERYL-10 PENTASTEARATEPMX5872701IACT
EUROPEAN ELDERBERRYBQY1UBX046IACT
SODIUM STEAROYL LACTYLATEIN99IT31LNIACT
LAVENDER OILZBP1YXW0H8IACT
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERYL MONOUNDECYLENATEIK8A76Q5G8IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
HELICHRYSUM ITALICUM FLOWER OILO97ZV7726KIACT
PHYTATE SODIUM88496G1ERLIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB

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
223d1623-16a1-1b1f-e063-6394a90a528d4c6e4fd7-3306-2936-e054-00144ff8d46c2024-09-16WarningsExact identifier
spl id: 223d1623-16a1-1b1f-e063-6394a90a528d
spl set id: 4c6e4fd7-3306-2936-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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