61010-8200, PAIN SPRAY

Manufacturer: Safetec of America, Inc.
Effective date: 2024-03-02
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-06-01 00:10:53

Label at a glance#

ProductAnalgesic

Active ingredientMENTHOL, UNSPECIFIED FORM

Label structure9 sections

Indications and uses

For the temporary relief of minor aches and pains of muscles and joints.

Dosage and administration

For adults and children 2 years of age and older: Shake well and apply to affected area not more than 3-4 times daily. Will not stain clothing. For children under 2 years of age, consult a doctor.

Contacts and useful links#

PhoneLabel contact800-456-7077

Websitewww.safetec.com

www.safetec.com

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Pain Spray

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

USP Menthol 7%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses:

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of muscles and joints.

Warnings:

WARNINGS SECTION

For external use only
Flammable.Keep away from flame.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children-if swallowed get medical help or contact a poison center right away. Avoid contact with eyes. Do not apply to open wounds or damaged skin. Do not bandage tightly. Consult a doctor if excessive skin irritation occurs, or if you are prone to allergic reactions to salicylates, including aspirin. If condition worsens, if symptoms persist for more than 7 days or clear up and recur again within a few days, discontinue use of this product and consult a doctor.

Directions:

DOSAGE & ADMINISTRATION SECTION

For adults and children 2 years of age and older: Shake well and apply to affected area not more than 3-4 times daily. Will not stain clothing. For children under 2 years of age, consult a doctor.

Other Information:

SPL UNCLASSIFIED SECTION

Store at room temperature.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Water, Isopropyl Alcohol, Glycerol, Eucalyptus Leaf Oil, Wintergreen Leaf Oil, Peppermint Oil, Coconut Oil.

Manufactured by
SAFETEC OF AMERICA, Inc. Buffalo, NY 14215
800-456-7077 www.safetec.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 61010-8200-1

Safetec

First Aid

Pain Spray

For Temporary

Pain Relief of

Minor Aches

And Pains

4 fl. oz. (118 ml)

PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1086713	menthol 7 % Topical Spray	PSN	2
1086713	menthol 70 MG/ML Topical Spray	SCD	2
1086713	menthol 7 % Topical Spray	SY	2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61010-8200-1	2024-04-09	C162847	48780-1	9d75b9cf-e7c5-f424-e053-dadaa90a57ce	61010-8200, PAIN SPRAY
61010-8200-1	2020-01-31	C162847	48780-1	9d75b9cf-e7c5-f424-e053-dadaa90a57ce	61010-8200, PAIN SPRAY

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61010-8200-1	Analgesic	118 mL in 1 BOTTLE, SPRAY	SPRAY	118		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61010-8200	ANALGESIC (MENTHOL) SPRAY [SAFETEC OF AMERICA, INC.]	2	Current NDC, Legacy NDC, 1 package rows	20240410_b0f4010c-995f-40e1-aa40-92760e697a61.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
menthol	ACTIVE INGREDIENT	L7T10EIP3A	1
menthol	ACTIVE MOIETY	L7T10EIP3A	1
coconut oil	INACTIVE INGREDIENT	Q9L0O73W7L	1
eucalyptus oil	INACTIVE INGREDIENT	2R04ONI662	1
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	1
isopropyl alcohol	INACTIVE INGREDIENT	ND2M416302	1
methyl salicylate	INACTIVE INGREDIENT	LAV5U5022Y	1
peppermint oil	INACTIVE INGREDIENT	AV092KU4JH	1
water	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

Analgesic
menthol
WATER
ISOPROPYL ALCOHOL
GLYCERIN
EUCALYPTUS OIL
METHYL SALICYLATE
PEPPERMINT OIL
COCONUT OIL
MENTHOL, UNSPECIFIED FORM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
61010-8200	61010-8200-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
WATER	059QF0KO0R	IACT
ISOPROPYL ALCOHOL	ND2M416302	IACT
GLYCERIN	PDC6A3C0OX	IACT
EUCALYPTUS OIL	2R04ONI662	IACT
METHYL SALICYLATE	LAV5U5022Y	IACT
PEPPERMINT OIL	AV092KU4JH	IACT
COCONUT OIL	Q9L0O73W7L	IACT
MENTHOL, UNSPECIFIED FORM	L7T10EIP3A	ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 64 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
methyl salicylate	METHYL SALICYLATE	LAV5U5022Y	POWDER / TOPICAL	NA		Exact identifier — unii+route 4 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	AEROSOL / TOPICAL	3 %w/w		Exact identifier — unii+route 32 equally ranked IID candidates
isopropyl alcohol	ISOPROPYL ALCOHOL	ND2M416302	GEL / TOPICAL		75 mg	Exact identifier — unii+route 14 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	GEL / TOPICAL		500 mg	Exact identifier — unii+route 32 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SOAP / TOPICAL	0.76 %w/w		Exact identifier — unii+route 32 equally ranked IID candidates
isopropyl alcohol	ISOPROPYL ALCOHOL	ND2M416302	LOTION, AUGMENTED / TOPICAL		2070 mg	Exact identifier — unii+route 14 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SOAP / TOPICAL	0.76 %w/w		Exact identifier — unii+route 32 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SYSTEM / TOPICAL		18144 mg	Exact identifier — unii+route 32 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SHAMPOO / TOPICAL	5 %w/w		Exact identifier — unii+route 32 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	GEL / TOPICAL		500 mg	Exact identifier — unii+route 32 equally ranked IID candidates
methyl salicylate	METHYL SALICYLATE	LAV5U5022Y	GEL / TOPICAL	0.05 %w/w		Exact identifier — unii+route 4 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	JELLY / TOPICAL	NA		Exact identifier — unii+route 32 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	CREAM, AUGMENTED / TOPICAL		55 mg	Exact identifier — unii+route 32 equally ranked IID candidates
peppermint oil	PEPPERMINT OIL	AV092KU4JH	SHAMPOO / TOPICAL	0.2 %w/w		Exact identifier — unii+route 4 equally ranked IID candidates
isopropyl alcohol	ISOPROPYL ALCOHOL	ND2M416302	SOLUTION / TOPICAL	40 %w/v		Exact identifier — unii+route 14 equally ranked IID candidates
coconut oil	COCONUT OIL	Q9L0O73W7L	OINTMENT / TOPICAL	14.75 %w/w		Exact identifier — unii+route 8 equally ranked IID candidates
peppermint oil	PEPPERMINT OIL	AV092KU4JH	SHAMPOO / TOPICAL	0.2 %w/w		Exact identifier — unii+route 4 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	JELLY / TOPICAL	NA		Exact identifier — unii+route 32 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	LIQUID / TOPICAL	2.5 %w/w		Exact identifier — unii+route 32 equally ranked IID candidates
isopropyl alcohol	ISOPROPYL ALCOHOL	ND2M416302	OIL / TOPICAL		72 mg	Exact identifier — unii+route 14 equally ranked IID candidates
isopropyl alcohol	ISOPROPYL ALCOHOL	ND2M416302	SWAB / TOPICAL	43.9 %w/w		Exact identifier — unii+route 14 equally ranked IID candidates
isopropyl alcohol	ISOPROPYL ALCOHOL	ND2M416302	LOTION, AUGMENTED / TOPICAL		2070 mg	Exact identifier — unii+route 14 equally ranked IID candidates
coconut oil	COCONUT OIL	Q9L0O73W7L	SOLUTION / TOPICAL	15.5 %w/w		Exact identifier — unii+route 8 equally ranked IID candidates
isopropyl alcohol	ISOPROPYL ALCOHOL	ND2M416302	OIL / TOPICAL		72 mg	Exact identifier — unii+route 14 equally ranked IID candidates
eucalyptus oil	EUCALYPTUS OIL	2R04ONI662	SYRUP / ORAL	NA		Exact identifier — unii candidate 2 equally ranked IID candidates
isopropyl alcohol	ISOPROPYL ALCOHOL	ND2M416302	GEL / TOPICAL		75 mg	Exact identifier — unii+route 14 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	CLOTH / TOPICAL	0.05 mg/mg		Exact identifier — unii+route 32 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION / TOPICAL		1971 mg	Exact identifier — unii+route 32 equally ranked IID candidates
coconut oil	COCONUT OIL	Q9L0O73W7L	SOAP / TOPICAL	4.6 %w/w		Exact identifier — unii+route 8 equally ranked IID candidates
peppermint oil	PEPPERMINT OIL	AV092KU4JH	OINTMENT / TOPICAL	0.2 %w/w		Exact identifier — unii+route 4 equally ranked IID candidates
methyl salicylate	METHYL SALICYLATE	LAV5U5022Y	GEL / TOPICAL	0.05 %w/w		Exact identifier — unii+route 4 equally ranked IID candidates
peppermint oil	PEPPERMINT OIL	AV092KU4JH	OINTMENT / TOPICAL	0.2 %w/w		Exact identifier — unii+route 4 equally ranked IID candidates
coconut oil	COCONUT OIL	Q9L0O73W7L	AEROSOL, FOAM / TOPICAL	23.6 %w/w		Exact identifier — unii+route 8 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION / TOPICAL		1971 mg	Exact identifier — unii+route 32 equally ranked IID candidates
isopropyl alcohol	ISOPROPYL ALCOHOL	ND2M416302	GEL, METERED / TOPICAL		525 mg	Exact identifier — unii+route 14 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SPRAY / NASAL	22.3 mg/1ml		Exact identifier — unii+dosage form 32 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SYSTEM / TOPICAL		18144 mg	Exact identifier — unii+route 32 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	CREAM / TOPICAL		1720 mg	Exact identifier — unii+route 32 equally ranked IID candidates
isopropyl alcohol	ISOPROPYL ALCOHOL	ND2M416302	GEL, METERED / TOPICAL		525 mg	Exact identifier — unii+route 14 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SPONGE / TOPICAL	2 %w/w		Exact identifier — unii+route 32 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	OINTMENT / TOPICAL	NA		Exact identifier — unii+route 32 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	LIQUID / TOPICAL	2.5 %w/w		Exact identifier — unii+route 32 equally ranked IID candidates
coconut oil	COCONUT OIL	Q9L0O73W7L	OINTMENT / TOPICAL	14.75 %w/w		Exact identifier — unii+route 8 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	LOTION / TOPICAL		3990 mg	Exact identifier — unii+route 32 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SPRAY / NASAL	22.3 mg/1ml		Exact identifier — unii+dosage form 32 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	CREAM / TOPICAL		1720 mg	Exact identifier — unii+route 32 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	AEROSOL, FOAM / TOPICAL		21 mg	Exact identifier — unii+route 32 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	OINTMENT / TOPICAL	NA		Exact identifier — unii+route 32 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	AEROSOL, FOAM / TOPICAL		21 mg	Exact identifier — unii+route 32 equally ranked IID candidates
isopropyl alcohol	ISOPROPYL ALCOHOL	ND2M416302	SOLUTION / TOPICAL	40 %w/v		Exact identifier — unii+route 14 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	LOTION / TOPICAL		3990 mg	Exact identifier — unii+route 32 equally ranked IID candidates
coconut oil	COCONUT OIL	Q9L0O73W7L	SOLUTION / TOPICAL	15.5 %w/w		Exact identifier — unii+route 8 equally ranked IID candidates
isopropyl alcohol	ISOPROPYL ALCOHOL	ND2M416302	SPONGE / TOPICAL	4 %w/w		Exact identifier — unii+route 14 equally ranked IID candidates
coconut oil	COCONUT OIL	Q9L0O73W7L	AEROSOL, FOAM / TOPICAL	23.6 %w/w		Exact identifier — unii+route 8 equally ranked IID candidates
isopropyl alcohol	ISOPROPYL ALCOHOL	ND2M416302	SPONGE / TOPICAL	4 %w/w		Exact identifier — unii+route 14 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	AEROSOL / TOPICAL	3 %w/w		Exact identifier — unii+route 32 equally ranked IID candidates
eucalyptus oil	EUCALYPTUS OIL	2R04ONI662	SYRUP / ORAL	NA		Exact identifier — unii candidate 2 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	CLOTH / TOPICAL	0.05 mg/mg		Exact identifier — unii+route 32 equally ranked IID candidates
isopropyl alcohol	ISOPROPYL ALCOHOL	ND2M416302	SWAB / TOPICAL	43.9 %w/w		Exact identifier — unii+route 14 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SHAMPOO / TOPICAL	5 %w/w		Exact identifier — unii+route 32 equally ranked IID candidates

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
Analgesic	MENTHOL	Safetec of America, Inc.	b0f4010c-995f-40e1-aa40-92760e697a61	2024-03-02	Warnings	Exact identifier ndc (package): 61010-8200-1 ndc (product): 61010-8200 ndc11 (package): 61010820001 spl id: 12b7defb-8710-5fd7-e063-6294a90a8a03 spl set id: b0f4010c-995f-40e1-aa40-92760e697a61

Reported adverse events (FAERS/openFDA)#

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

61010-8200, PAIN SPRAY

Label at a glance#

Indications and uses

Dosage and administration

Contacts and useful links#

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Active Ingredients

Purpose

Uses:

Warnings:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions:

Other Information:

Inactive Ingredients:

PRINCIPAL DISPLAY PANEL

Related RxNorm Concepts#

DailyMed RxNorm Mappings#

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

DailyMed Dashboard NDC Coverage#

DailyMed Socrata Ingredients#

Products#

NDC Codes#

Ingredients#

Source Document#

Inactive ingredient matches#

openFDA label cross-check#

Reported adverse events (FAERS/openFDA)#