FDA.reportPublic FDA data

LID O CREME ROLL ON

Manufacturer
Pharma Natural, Inc.
Effective date
2018-08-31
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:56:42

Label at a glance#

ProductLID O CREME ROLL ON
Active ingredientMENTHOL, LIDOCAINE HYDROCHLORIDE
Label structure9 sections

Dosage and administration

▪ 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: consult a doctor

Label contents#

Full prescribing information#

Active ingredients and Purpose

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
Lidocaine HCL 4%............................Topical analgesic
Menthol 1%.......................................Topical analgesic

Use

INDICATIONS & USAGE SECTION

For the temporary relief of pain.

Warnings

WARNINGS SECTION

For external use only. Avoid contact with the eyes.

Do not use

OTC - DO NOT USE SECTION

in large quantities, particularly over raw surfaces, or blistered areas.

Stop use and ask a doctor if

OTC - STOP USE SECTION

condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

If pregnant or breast feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

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 immediately.

Directions

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: consult a doctor

Other information

OTHER SAFETY INFORMATION

▪ store in a cool dry place between (59-86°F)15-30°C

▪ don’t use if seal over cap is broken, torn, or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe vera leaf, alpha-tocopherol, arnica montana flower, caprylhydroxamic acid, caprylyl glycol, cyclomethicone 5, dimethicone, dimethyl sulfone, glycerin, glyceryl monostearate, glycol stearate, methylpropanediol, PEG-100 stearate, PEG/PPG-18/18-dimethicone, phenoxyethanol, sodium lauryl sulfate, sodium polyacrylate, stearyl alcohol, sweet almond oil, trideceth-6, water

Questions or comments?

OTC - QUESTIONS SECTION

+1-305-231-8977 (M-F) 9 A.M. - 5 P.M. EST or www.pharmanatural.com

Manufactured & Distributed by:

SPL UNCLASSIFIED SECTION

Pharma Natural, Inc.

Hialeah, FL 33016

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PAIN RELIEVING

Pharma Natural

Natural Health Solutions

Lid O Creme

Maximum Strength

Topical Analgesic Cream

Roll-On

LIDOCAINE HCL 4%

MENTHOL 1%

2.5 oz. (71 g)

LIDOCREME_LABELLIDOCREME_LABEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1595624lidocaine HCl 4 % / menthol 1 % Topical CreamPSN2
1595624lidocaine hydrochloride 40 MG/ML / menthol 10 MG/ML Topical CreamSCD2
1595624lidocaine hydrochloride 4 % / menthol 1 % Topical CreamSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63788-111-252020-01-31C16284748780-19d75b9d0-9097-f424-e053-dadaa90a57ceLID O CREME

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63788-111-25LID O CREME ROLL ON71 g in 1 BOTTLE, WITH APPLICATORCREAM712

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63788-111LID O CREME ROLL ON (LIDOCAINE HCL, MENTHOL) CREAM [PHARMA NATURAL, INC.]2Legacy NDC, 1 package rows20180901_6fca06cb-fda0-e36c-e053-2991aa0ad6a8.zip

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63788-11163788-111-25

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
SODIUM LAURYL SULFATE368GB5141JIACT
SODIUM POLYACRYLATE (8000 MW)285CYO341LIACT
TRIDECETH-63T5PCR2H0CIACT
WATER059QF0KO0RIACT
MENTHOLL7T10EIP3AACTIB
ALOE VERA LEAFZY81Z83H0XIACT
ALPHA-TOCOPHEROLH4N855PNZ1IACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
DIMETHICONE92RU3N3Y1OIACT
GLYCOL STEARATE0324G66D0EIACT
METHYLPROPANEDIOLN8F53B3R4RIACT
ALMOND OIL66YXD4DKO9IACT
PHENOXYETHANOLHIE492ZZ3TIACT
PEG-100 STEARATEYD01N1999RIACT
PEG/PPG-18/18 DIMETHICONE9H0AO7T794IACT
CAPRYLYL GLYCOL00YIU5438UIACT
CYCLOMETHICONE 50THT5PCI0RIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
STEARYL ALCOHOL2KR89I4H1YIACT

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
74c598b4-ef73-b4fa-e053-2991aa0a223a6fca06cb-fda0-e36c-e053-2991aa0ad6a82018-08-31WarningsExact identifier
spl id: 74c598b4-ef73-b4fa-e053-2991aa0a223a
spl set id: 6fca06cb-fda0-e36c-e053-2991aa0ad6a8

Reported adverse events (FAERS/openFDA)#

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