Bactine ® Max Pain Relieving Cleansing Spray

Manufacturer: WellSpring Pharmaceutical Corporation
Effective date: 2022-12-27
Label type: HUMAN OTC DRUG LABEL
Version: 6
Source: full-release
Hydrated at: 2026-06-01 00:51:26

Label at a glance#

ProductBactine Max Dry

Active ingredientLIDOCAINE HYDROCHLORIDE

Label structure11 sections

Indications and uses

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

Dosage and administration

■ adults and children over 12 years: ■ spray affected area every 6 to 8 hours, not to exceed 3 to 4 applications in a 24 hour period ■ product will dry quickly on its own, and does not need to be rubbed in ■ children 12 years or younger: ask a doctor

Contacts and useful links#

PhoneLabel contact1-844-241-5454

Websitewww.bactine.com

www.bactine.com

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Purpose

OTC - PURPOSE SECTION

Pain Relieving Spray

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only

Do not Use

OTC - ASK DOCTOR SECTION

■ in large quantities, particularly over raw surfaces or blister areas

■ on puncture wounds

■ in or near the eyes

■ longer than 1 week unless directed by a doctor

When using this product

OTC - WHEN USING SECTION

■ use only as directed. Read and follow all directions and warnings on this label.

■ do not allow contact with the eyes and mucous membranes

■ avoid spraying on face

■ avoid inhalation of spray

■ do not bandage or apply local heat (such as heating pads) or a medicated patch to area of use

■ do not use at the same time as other topical analgesics

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

Extremely Flammable

WARNINGS SECTION

■ do not use near heat or flame or while smoking

■ avoid long term storage above 104°F (40°C)

■ do not puncture or incinerate. Contents under pressure.

■ do not store at temperatures above 120°F (49°C)

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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

■ adults and children over 12 years:

■ spray affected area every 6 to 8 hours, not to exceed 3 to 4 applications in a 24 hour period

■ product will dry quickly on its own, and does not need to be rubbed in

■ children 12 years or younger: ask a doctor

SAFE HANDLING WARNING SECTION

Child-resistant packaging. Replace cap after each use

Inactive ingredients

INACTIVE INGREDIENT SECTION

alcohol denat. (28 %)

anthemis nobilis flower oil

aqua

arnica montana flower extract

calendula officinalis flower extract

Caprylic/Capric Triglyceride

glycerin

isobutane

propylene glycol

Questions?

OTC - QUESTIONS SECTION

1-844-241-5454 or www.bactine.com

Distributed by:

SPL UNCLASSIFIED SECTION

WellSpring Pharmaceutical Corporation

Sarasota, FL 34243

Pharmaceutical Corporation

MONEYBACK GUARANTEE

Bactine max is FSA/HSA eligible

DOT 2Q M5706

Extremely Flammable

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW

NDC 65197-815-04

Bactine MAX

LIDOCAINE Dry Spray

Anesthetic

NUMBS AWAY PAIN AND ITCH

MAX RELIEF FOR Minor Cuts & Scrapes, Burns, Bug bites & Sunburn

QUICK-DRY

4oz (113g)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1869797	lidocaine 4 % Topical Spray	PSN	6
1869797	lidocaine 40 MG/ML Topical Spray	SCD	6
1869797	lidocaine 4 % Topical Spray	SY	6

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
LIDOCAINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
070fbed5-7088-434a-a7ce-f2a64d8d40ac	Product name	2	20260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80f	Product name	5	20250819
860a93dc-4863-49cc-b284-6bbe8191bc48	Product name	4	20250214
eaba870a-6a9d-442e-8643-87b3f558a451	Product name	1	20250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86	Product name	1	20230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57	Product name	3	20210602
aed701d5-9c75-dfaf-7154-cde46179faea	Product name	9	20200313
fa8b5901-e681-426f-82fe-54f6d81ec698	Product name	4	20180619
332d03e4-aa24-4b11-841a-02bf41081920	Product name	1	20171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070	Product name	1	20171221
68ed98f8-24c2-44a0-944a-6d36e82ce25a	Product name	1	20141222
1cd42bc2-a430-c72b-636d-991b235fbf80	Product name	1	20140508
49fa150c-f0de-cce7-3d9c-993ed81c5698	Product name	1	20140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ff	Product name	1	20140508
9137811f-f279-8640-5aeb-99fa2145d64d	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
65197-815-04	Bactine Max Dry	113 g in 1 CAN	SPRAY	113		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65197-815	BACTINE MAX DRY (LIDOCAINE HYDROCHLORIDE) SPRAY [WELLSPRING PHARMACEUTICAL CORPORATION]	6	Current NDC, 1 package rows	20250110_466404cd-c46a-4944-b1ac-3b3b17f436a1.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65197-815-04	GM - Gram	65197-815	61621ba2-fb02-429b-977a-c1a8e3f21798	2	2025-02-10

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

Bactine Max Dry
lidocaine hydrochloride
LIDOCAINE
LIDOCAINE HYDROCHLORIDE ANHYDROUS
CHAMAEMELUM NOBILE FLOWER OIL
ARNICA MONTANA FLOWER
CALENDULA OFFICINALIS FLOWER
WATER
MEDIUM-CHAIN TRIGLYCERIDES
GLYCERIN
ISOBUTANE
PROPYLENE GLYCOL
ALCOHOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
65197-815	65197-815-04

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
Name	UNII	Kind
LIDOCAINE HYDROCHLORIDE	V13007Z41A	ACTIR
CHAMAEMELUM NOBILE FLOWER OIL	UB27587839	IACT
ARNICA MONTANA FLOWER	OZ0E5Y15PZ	IACT
CALENDULA OFFICINALIS FLOWER	P0M7O4Y7YD	IACT
WATER	059QF0KO0R	IACT
MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	IACT
GLYCERIN	PDC6A3C0OX	IACT
ISOBUTANE	BXR49TP611	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
ALCOHOL	3K9958V90M	IACT

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bactine Max Dry	LIDOCAINE HYDROCHLORIDE	WellSpring Pharmaceutical Corporation	466404cd-c46a-4944-b1ac-3b3b17f436a1	2022-12-27	Warnings	Exact identifier ndc (package): 65197-815-04 ndc (product): 65197-815 ndc11 (package): 65197081504 spl id: 144bf707-6b26-4386-a0ba-0a4a3a797be9 spl set id: 466404cd-c46a-4944-b1ac-3b3b17f436a1

Reported adverse events (FAERS/openFDA)#

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