ONEBACK

Manufacturer: WORLD WIDE MEDICAL SERVICES, INC.
Effective date: 2015-04-30
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:42:26

Label at a glance#

ProductONEBACK

Active ingredientMENTHOL

Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS

NATURAL MENTHOL 3.9%

OTC - PURPOSE SECTION

PURPOSE

COOLING PAIN RELIEF

INDICATIONS & USAGE SECTION

USES

TEMPORARY RELIEF OF

ARTHRITIS
BACKACHE
STRAINS
SPRAINS

WARNINGS SECTION

WARNINGS

FOR EXTERNAL USE ONLY

OTC - DO NOT USE SECTION

DO NOT USE NEAR EYES, MOUTH, MUCUS MEMBRANES, CUTS, RASHES, AND SORES. IF CONTACT OCCURS, FLUSH WITH COLD WATER.

DO NOT USE WITH HEATING PAD OR DEVICE, OR UNDER BANDAGE.

DO NOT USE IF PREGNANT OR BREAST FEEDING. PLEASE CONSULT YOUR PHYSICIAN PRIOR TO USE.

DO NOT APPLY TO WOUNDS OR DAMAGED SKIN.

OTC - STOP USE SECTION

STOP USE AND ASK A DOCTOR IF IRRITATION PERSISTS.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN. IF ACCIDENTALLY INGESTED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS

ADULTS AND CHILDREN 2 YEARS OF AGE AND OLDER: APPLY TO AFFECTED AREA NOT MORE THAN 3 TO 4 TIMES DAILY
RUB IN THOROUGHLY UNTIL IT IS ABSORBED.

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS

WATER, ISOPROPYL ALCOHOL, PROPYLENE GLYCOL, GLYCERINE, CARBOMER, ILEX PARAGUARIENSIS LEAF EXTRACT, HYDRATED SILICA, AMINOMETHYL PROPANOL, METHYL PARABEN, UNCARIA TOMENTOSA EXTRACT, BOSWEILA SERRATA EXTRACT, CAMPHOR FOR SCENT

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Cool Pain Relieving Gel 3oz. (2.13.2015)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1486765	menthol 3.9 % Topical Gel	PSN	1
1486765	menthol 0.039 MG/MG Topical Gel	SCD	1
1486765	menthol 3.9 % Topical Gel	SY	1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69643-101-11	2020-01-31	C162847	48780-1	9d75b9d0-c88f-f424-e053-dadaa90a57ce	740db6f0-e002-411b-95a4-3807fba6ff52

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69643-101-11	ONEBACK	88.8 mL in 1 BOTTLE	GEL	88.8		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69643-101	ONEBACK (MENTHOL) GEL [WORLD WIDE MEDICAL SERVICES, INC.]	1	Legacy NDC, 1 package rows	20150501_740db6f0-e002-411b-95a4-3807fba6ff52.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	1
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	1
AMINOMETHYLPROPANOL	INACTIVE INGREDIENT	LU49E6626Q	1
BOSWELLIA SERRATA RESIN OIL	INACTIVE INGREDIENT	5T1XCE6K8K	1
CAMPHOR OIL	INACTIVE INGREDIENT	75IZZ8Y727	1
CARBOMER 940	INACTIVE INGREDIENT	4Q93RCW27E	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	1
HYDRATED SILICA	INACTIVE INGREDIENT	Y6O7T4G8P9	1
ILEX PARAGUARIENSIS LEAF	INACTIVE INGREDIENT	1Q953B4O4F	1
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	1
UNCARIA TOMENTOSA LEAF	INACTIVE INGREDIENT	487U8M3D2P	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

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

ONEBACK
MENTHOL
WATER
ISOPROPYL ALCOHOL
PROPYLENE GLYCOL
GLYCERIN
CARBOMER 940
ILEX PARAGUARIENSIS LEAF
HYDRATED SILICA
AMINOMETHYLPROPANOL
METHYLPARABEN
UNCARIA TOMENTOSA LEAF
BOSWELLIA SERRATA RESIN OIL
CAMPHOR OIL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
69643-101	69643-101-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
MENTHOL	L7T10EIP3A	ACTIB
WATER	059QF0KO0R	IACT
ISOPROPYL ALCOHOL	ND2M416302	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
GLYCERIN	PDC6A3C0OX	IACT
CARBOMER 940	4Q93RCW27E	IACT
ILEX PARAGUARIENSIS LEAF	1Q953B4O4F	IACT
HYDRATED SILICA	Y6O7T4G8P9	IACT
AMINOMETHYLPROPANOL	LU49E6626Q	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
UNCARIA TOMENTOSA LEAF	487U8M3D2P	IACT
BOSWELLIA SERRATA RESIN OIL	5T1XCE6K8K	IACT
CAMPHOR OIL	75IZZ8Y727	IACT

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 5 · 255 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
GLYCERIN	GLYCERIN	PDC6A3C0OX	EMULSION / OPHTHALMIC		3 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION / SUBCUTANEOUS		450 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / DENTAL	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	TABLET, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 9 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / ORAL		32400 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / TOPICAL		216 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, EXTENDED RELEASE / ORAL		8 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	OINTMENT / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CREAM / TOPICAL		1720 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	FILM, EXTENDED RELEASE / BUCCAL		34 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	GEL, METERED / TOPICAL		525 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	EMULSION / OPHTHALMIC	1.5 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	GEL / TRANSDERMAL		500 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CONCENTRATE / ORAL		1800 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / VAGINAL		750 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / ORAL		346 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, SUSPENSION / INTRAMUSCULAR		1 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	DROPS / NASAL	26 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, EXTENDED RELEASE / ORAL		7 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	SPONGE / TOPICAL	4 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION, SOLUTION / INTRAVENOUS		4000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	FILM / BUCCAL	1.48 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE, COATED / ORAL	14.21 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 81 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CAPSULE, EXTENDED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, SOLUTION / PARENTERAL		30 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION, EXTENDED RELEASE / ORAL		1000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	GUM, CHEWING / BUCCAL		230 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET / ORAL		64 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / AURICULAR (OTIC)	10 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CONCENTRATE / ORAL		7000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CONCENTRATE / ORAL		12 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
AMINOMETHYLPROPANOL	AMINOMETHYLPROPANOL	LU49E6626Q	LOTION / TOPICAL	0.3 %w/w		Exact identifier — unii candidate 2 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION/ DROPS / AURICULAR (OTIC)		25 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / INTRAMUSCULAR	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / IRRIGATION	2 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	TABLET, COATED / ORAL	0.8 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION/ DROPS / ORAL		750 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, SOLUTION / INTRAMUSCULAR		45 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	TABLET / ORAL	1.8 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, EXTENDED RELEASE / ORAL	9 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	63.4 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	TABLET, CHEWABLE / ORAL	1.28 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CAPSULE / ORAL		7 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / INTRAMUSCULAR	0.13 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / TOPICAL	5.28 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	DOUCHE / VAGINAL	1 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / INTRAMUSCULAR		95 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / OPHTHALMIC	0.44 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
CARBOMER 940	CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	4Q93RCW27E	GEL / TRANSDERMAL		150 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUPPOSITORY / VAGINAL	252 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	ENEMA / RECTAL	0.18 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION / INTRAVENOUS		16624 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION / ORAL		26208 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	DROPS / AURICULAR (OTIC)	0.01 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / EPIDURAL	1 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / TOPICAL	0.24 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CREAM / VAGINAL		1225 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / RESPIRATORY (INHALATION)	25 %w/w		Exact identifier — unii candidate 81 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
3b6d85e0-ea4b-4b96-b73a-bbcdae142a3f			740db6f0-e002-411b-95a4-3807fba6ff52	2015-04-30	Warnings	Exact identifier spl id: 3b6d85e0-ea4b-4b96-b73a-bbcdae142a3f spl set id: 740db6f0-e002-411b-95a4-3807fba6ff52

Reported adverse events (FAERS/openFDA)#

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