FDA.reportPublic FDA data

GREEN GUARD Topical Pain Relief

Manufacturer
Ultra Distributors Inc
Effective date
2025-04-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:58:47

Label at a glance#

ProductGREEN GUARD Topical Pain Relief
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure12 sections

Indications and uses

Temporary pain relief associated with minor burns

Dosage and administration

spray an even layer of burn spray over cleaned affected area not more than 3-4 times daily not to be used on Children under 12 years of age

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCI 2.0%

Purpose

OTC - PURPOSE SECTION

Topical pain relief

Uses

INDICATIONS & USAGE SECTION

Temporary pain relief associated with minor burns

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

  • in large quantities, particularly over raw or blistered areas
  • near eyes, if this happens rinse thoroughly with water

Stop use and ask a doctor

OTC - STOP USE SECTION

if condition worsens or persists for more than 7 days or clears up and returns.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • spray an even layer of burn spray over cleaned affected area not more than 3-4 times daily
  • not to be used on Children under 12 years of age

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydroxypropyl methylcellulose, melaleuca alterniflia (tea tree) leaf oil, octoxynol 9,PEG-40 hydrogenated castor oil, phenoxyethanol, propylene glycol, triethanolamine, water

Questions or comments?

OTC - QUESTIONS SECTION

1-800-869-6970

SPL UNCLASSIFIED SECTION

Topical Pain Relief

Relieves pain of minor burns

Store at 68°-77°F (20°-25°C)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of bottle labelimage of bottle label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1010769lidocaine HCl 2 % Topical SprayPSN2
1010769lidocaine hydrochloride 20 MG/ML Topical SpraySCD2
1010769lidocaine hydrochloride 2 % Topical SpraySY2

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78495-132-012025-04-07C16284748780-12cef2736-afb2-d83d-e063-dadaa90ab31f78495-132
78495-132-012025-01-30C16284748780-12cef2736-afb2-d83d-e063-dadaa90ab31f78495-132

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78495-132-01GREEN GUARD Topical Pain Relief59.1 mL in 1 BOTTLE, SPRAYSPRAY59.12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78495-132GREEN GUARD TOPICAL PAIN RELIEF (LIDOCAINE HCI) SPRAY [ULTRA DISTRIBUTORS INC]2Current NDC, Legacy NDC, 1 package rows20250409_b6f0041c-47fc-0bcd-e053-2a95a90ab1f9.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78495-13278495-132-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
GLYCERINPDC6A3C0OXIACT
OCTOXYNOL-97JPC6Y25QSIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
TROLAMINE9O3K93S3TKIACT
HYPROMELLOSES3NXW29V3WOIACT
TEA TREE OILVIF565UC2GIACT

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
GREEN GUARD Topical Pain ReliefLIDOCAINE HCIUltra Distributors Incb6f0041c-47fc-0bcd-e053-2a95a90ab1f92025-04-07WarningsExact identifier
ndc (package): 78495-132-01
ndc (product): 78495-132
ndc11 (package): 78495013201
spl id: 3239add3-7926-c1a3-e063-6394a90a1310
spl set id: b6f0041c-47fc-0bcd-e053-2a95a90ab1f9

Reported adverse events (FAERS/openFDA)#

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