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PROSTAT FIRST AID Burn Ease, 0.9g

58228-3867-1 PS-3866 Burn Ease 0.9g

Approved
Approval ID

dc704403-e2aa-47f7-a7f4-f6afe1547ca8

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Oct 1, 2025

Manufacturers
FDA

ProStat First Aid LLC

DUNS: 061263699

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

LIDOCAINE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code58228-3867
Application NumberM017
Product Classification
M
Marketing Category
C200263
G
Generic Name
LIDOCAINE
Product Specifications
Route of AdministrationTOPICAL
Effective DateOctober 1, 2025
FDA Product Classification

INGREDIENTS (11)

CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: 4Q93RCW27E
Classification: IACT
AMINOMETHYL PROPANOLInactive
Code: LU49E6626Q
Classification: IACT
ETHYLHEXYLGLYCERINInactive
Code: 147D247K3P
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
MENTHOLInactive
Code: L7T10EIP3A
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
.ALPHA.-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0
Classification: IACT
ALOE BARBADENSIS LEAF JUICEInactive
Code: RUE8E6T4NB
Classification: IACT
LIDOCAINE HYDROCHLORIDEActive
Quantity: 2 g in 100 g
Code: V13007Z41A
Classification: ACTIR

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/30/2025

image description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/17/2025

Use(s)

Temporary pain relief associated with minor burns

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/30/2025

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Aminomethyl propanol, Carbomer, Ethylhexylglycerin, Maltodextrin, Menthol, Polyethylene glycol, Phenoxyethanol, Tocopheryl Acetate, Water

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 9/17/2025

Questions?

1-888-900-2920 8AM - 4PM PST

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 9/17/2025

Other Information

• store at 68-77F (20-25C)

  • tamper evident sealed packets

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/30/2025

Active Ingredient

Lidocaine Hydrochloride 2%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/17/2025

Purpose

Topical Pain Relief

WARNINGS SECTION

LOINC: 34071-1Updated: 9/30/2025

Warnings

For External Use Only

Do not use

• any opened or torn packets

• in large quantities, particularly over raw or blistered areas

  • Near eyes. If this happens, rinse thoroughly with water

• Avoid contact with the eyes

• Do not bandage tightly

Stop use and ask a doctor if

• Condition worsens or persists for more than 7 days or clears up and returns

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/17/2025

Directions

Apply an even layer of burn gel over cleaned affected area not more than 3-4 times daily

Not to be used on children under 12 years of age

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PROSTAT FIRST AID Burn Ease, 0.9g - FDA Drug Approval Details