Bactine® - DailyMed Details

Bactine®

SPL v6

SPL

SPL Set ID 466404cd-c46a-4944-b1ac-3b3b17f436a1

Route

TOPICAL

Published

Effective Date 2022-12-27

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients

Chamaemelum Nobile Flower Oil Arnica Montana Flower Calendula Officinalis Flower Water Medium-chain Triglycerides Glycerin Isobutane Propylene Glycol Alcohol

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-01-31

Description

Drug Facts

Purpose

Pain Relieving Spray

Medication Information

Purpose

Pain Relieving Spray

Description

Drug Facts

Uses

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

Section 42229-5

Drug Facts

Section 50741-8

Child-resistant packaging. Replace cap after each use

Warnings

For external use only

Directions

■ 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

Do Not Use

■ 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

Questions?

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

Distributed By:

WellSpring Pharmaceutical Corporation

Sarasota, FL 34243

Pharmaceutical Corporation

MONEYBACK GUARANTEE

Bactine max is FSA/HSA eligible

DOT 2Q M5706

Extremely Flammable

Active Ingredients

Lidocaine 4%

Extremely Flammable

■ 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)

Inactive Ingredients

alcohol denat. (28 %)

anthemis nobilis flower oil

aqua

arnica montana flower extract

calendula officinalis flower extract

Caprylic/Capric Triglyceride

glycerin

isobutane

propylene glycol

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)

Bactine Dry Spray 113g

When Using This Product

■ 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

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

If Pregnant Or Breast Feeding

ask a health professional before use.

Keep Out of Reach of Children.

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

Structured Label Content

Uses

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

Section 42229-5 (42229-5)

Drug Facts

Section 50741-8 (50741-8)

Child-resistant packaging. Replace cap after each use

Purpose

Pain Relieving Spray

Warnings

For external use only

Directions

■ 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

Do Not Use (Do not Use)

■ 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

Questions?

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

Distributed By: (Distributed by:)

WellSpring Pharmaceutical Corporation

Sarasota, FL 34243

Pharmaceutical Corporation

MONEYBACK GUARANTEE

Bactine max is FSA/HSA eligible

DOT 2Q M5706

Extremely Flammable

Active Ingredients

Lidocaine 4%

Extremely Flammable

■ 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)

Inactive Ingredients (Inactive ingredients)

alcohol denat. (28 %)

anthemis nobilis flower oil

aqua

arnica montana flower extract

calendula officinalis flower extract

Caprylic/Capric Triglyceride

glycerin

isobutane

propylene glycol

Principal Display Panel (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)

Bactine Dry Spray 113g

When Using This Product (When using this product)

■ 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 (Stop use and ask a doctor if)

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

If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Advanced Ingredient Data

[{"name": "LIDOCAINE HYDROCHLORIDE ANHYDROUS", "unii": "EC2CNF7XFP", "classCode": "ACTIR", "strengthNumerator": "4", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "CHAMAEMELUM NOBILE FLOWER OIL", "unii": "UB27587839", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ARNICA MONTANA FLOWER", "unii": "OZ0E5Y15PZ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CALENDULA OFFICINALIS FLOWER", "unii": "P0M7O4Y7YD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MEDIUM-CHAIN TRIGLYCERIDES", "unii": "C9H2L21V7U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOBUTANE", "unii": "BXR49TP611", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites or minor skin irritations.", "42229-5": "Drug Facts", "50741-8": "Child-resistant packaging. Replace cap after each use", "Purpose": "Pain Relieving Spray ", "Warnings": "For external use only", "Directions": "■ 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", "Do not Use": "■ 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", "Questions?": "1-844-241-5454 or www.bactine.com", "Distributed by:": "WellSpring Pharmaceutical Corporation Sarasota, FL 34243 ©2022 Wellspring Pharmaceutical Corporation MONEYBACK GUARANTEE Bactine max is FSA/HSA eligible DOT 2Q M5706 Extremely Flammable", "Active Ingredients": "Lidocaine 4%", "Extremely Flammable": "■ 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)", "Inactive ingredients": "alcohol denat. (28 %) anthemis nobilis flower oil aqua arnica montana flower extract calendula officinalis flower extract Caprylic/Capric Triglyceride glycerin isobutane propylene glycol", "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) Bactine Dry Spray 113g", "When using this product": "■ 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": "condition worsens symptoms persist for more than 7 days, or clear up and occur again within a few days", "If pregnant or breast-feeding": "ask a health professional before use.", "Keep out of reach of children.": " If swallowed, get medical help or contact a Poison Control Center right away."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:16.016303 · Updated: 2026-03-14T23:06:47.753582