FDA.reportPublic FDA data

Active Ingredient

Manufacturer
Prodigy Media Inc
Effective date
2026-06-03
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
daily-update
Hydrated at
2026-06-06 05:10:18

Label at a glance#

ProductPURE PRIMAL DELAY
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCL 4%

Purpose

OTC - PURPOSE SECTION

External Analgesic

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

  • For external use only.
  • Avoid contact with eyes

Stop use and ask a doctor if

  • Condition worsens or symptoms persist for more than 7 days
  • Symptoms clear up and occur again within a few days
  • Do not use in large quantities, particularly over raw surfaces or blistered areas. Do not exceed the recommended daily dosage unless directed by a doctor.

Do not use

  • On wounds or damaged skin.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Direction

DOSAGE & ADMINISTRATION SECTION

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: do not use, consult a physician.

Other information

SPL UNCLASSIFIED SECTION

Do not use if seal is broken.

Inactive ingredients

INACTIVE INGREDIENT SECTION

CYCLOMETHICONE
Emu Oil
Ethoxydiglycol
Ethylhexylglycerin
Glycerin
Isopropyl Myristate
Phenoxyethanol
Polyacrylate Crosspolymer-6
Polysorbate 60
Water
Xanthan Gum

SPL UNCLASSIFIED SECTION

Questions? 866-488-0066

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PPM Delay LabelPPM Delay LabelPPM Delay BoxPPM Delay Box

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70171-006070171-0060-1

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
WATER059QF0KO0RIACT
CYCLOMETHICONENMQ347994ZIACT
ETHOXYDIGLYCOLA1A1I8X02BIACT
GLYCERINPDC6A3C0OXIACT
EMU OIL344821WD61IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYACRYLATE CROSSPOLYMER-6Q7UI015FF9IACT
XANTHAN GUMTTV12P4NEEIACT
POLYSORBATE 60CAL22UVI4MIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12025-07-28full-release2026-06-01 01:08:42

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
PURE PRIMAL DELAYLIDOCAINE HCLProdigy Media Inc1ddab664-7c44-452f-854f-e386cd69505e2026-06-03WarningsExact identifier
ndc (package): 70171-0060-1
ndc (product): 70171-0060
ndc11 (package): 70171006001
spl id: 535f66da-cd79-3c26-e063-6294a90a0798
spl set id: 1ddab664-7c44-452f-854f-e386cd69505e

Reported adverse events (FAERS/openFDA)#

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