Hot spot

Manufacturer: Fabrication Enterprises, inc. | Pure Source
Effective date: 2011-10-13
Label type: HUMAN OTC DRUG LABEL
Version: 9
Source: full-release
Hydrated at: 2026-05-31 22:30:18

Label at a glance#

ProductHot spot point relief

Active ingredientCAPSAICIN

Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

acitve ingredients: capsaicin

INACTIVE INGREDIENT SECTION

aqua (deionized water), carbomer, cassia oil, choldroitin sulfate, ethylhexylglycerine, glucosamine sulfate, glycrrhiza glabra (licorice) extract, phenoxyethanol, polysorbate-20

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of children. if swallowed consult physician.

WARNINGS SECTION

for external use only

avoid contact with eyes

do not apply to open wounds or damaged skin

if symptoms persist for more than seven days, discontinue use and consult physician

keep out of reach of children. if swallowed, consult physician.

do not bandage tightly

OTC - PURPOSE SECTION

external analesic

INDICATIONS & USAGE SECTION

for temprorary relief of minor aches and pains of the muscles and joints associated with simple backache, arthritis, bruises, strains and/or sprains.

DOSAGE & ADMINISTRATION SECTION

apply directly to affected area. do not use more than four times per day.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1043201	capsaicin 0.06 % Topical Gel	PSN	9
1043205	HotSpot POINT RELIEF 0.06 % Topical Gel	PSN	9
1043205	capsaicin 0.0006 MG/MG Topical Gel [Hot Spot]	SBD	9
1043201	capsaicin 0.0006 MG/MG Topical Gel	SCD	9
1043201	capsaicin 0.06 % Topical Gel	SY	9
1043205	Hot Spot 0.0006 MG/MG Topical Gel	SY	9
1043205	Hot Spot Point Relief 0.06 % Topical Gel	SY	9

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
473d070d-1c38-488e-b991-c4d1bf45aab8	Product name	1	20210201

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51452-010-00	2019-11-13	C162847	48780-1	97449f38-cd55-f6ea-e053-dbdaa90aa703	Hot Spot Point Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51452-010-00	Hot spotpoint relief	5 mL in 1 PACKET	GEL	5		9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51452-010	HOT SPOT POINT RELIEF (CAPSAICIN) GEL [FABRICATION ENTERPRISES, INC.]	9	Legacy NDC, 1 package rows	20111212_b2096fa2-f35d-44bb-b3cf-5ff877c0614c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
CAPSAICIN	ACTIVE INGREDIENT	S07O44R1ZM	9
CAPSAICIN	ACTIVE MOIETY	S07O44R1ZM	9
CARBOMER 1342	INACTIVE INGREDIENT	809Y72KV36	9
CASSIA FISTULA FRUIT	INACTIVE INGREDIENT	J65X53KM9E	9
CHONDROITIN SULFATE (BOVINE)	INACTIVE INGREDIENT	6IC1M3OG5Z	9
ETHYLHEXYLGLYCERIN	INACTIVE INGREDIENT	147D247K3P	9
Glucosamine sulfate	INACTIVE INGREDIENT	1FW7WLR731	9
GLYCYRRHIZA GLABRA	INACTIVE INGREDIENT	2788Z9758H	9
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	9
polysorbate 20	INACTIVE INGREDIENT	7T1F30V5YH	9
water	INACTIVE INGREDIENT	059QF0KO0R	9

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

Hot spot point relief
CAPSAICIN
water
polysorbate 20
CHONDROITIN SULFATE (BOVINE)
Glucosamine sulfate
GLYCYRRHIZA GLABRA
CARBOMER 1342
PHENOXYETHANOL
CASSIA FISTULA FRUIT
ETHYLHEXYLGLYCERIN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
51452-010	51452-010-00

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
CAPSAICIN	S07O44R1ZM	ACTIB
water	059QF0KO0R	IACT
polysorbate 20	7T1F30V5YH	IACT
CHONDROITIN SULFATE (BOVINE)	6IC1M3OG5Z	IACT
Glucosamine sulfate	1FW7WLR731	IACT
GLYCYRRHIZA GLABRA	2788Z9758H	IACT
CARBOMER 1342	809Y72KV36	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT
CASSIA FISTULA FRUIT	J65X53KM9E	IACT
ETHYLHEXYLGLYCERIN	147D247K3P	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 1 · 40 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
polysorbate 20	POLYSORBATE 20	7T1F30V5YH	TABLET, FILM COATED / ORAL	0.35 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
polysorbate 20	POLYSORBATE 20	7T1F30V5YH	SPRAY, METERED / NASAL		40 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
polysorbate 20	POLYSORBATE 20	7T1F30V5YH	INJECTION / INTRAVENOUS		30 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	AEROSOL / TOPICAL	1.05 %w/w		Exact identifier — unii candidate 6 equally ranked IID candidates
polysorbate 20	POLYSORBATE 20	7T1F30V5YH	AEROSOL, FOAM / TOPICAL	3.7 %w/w		Exact identifier — unii candidate 28 equally ranked IID candidates
polysorbate 20	POLYSORBATE 20	7T1F30V5YH	CAPSULE / ORAL		563 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
polysorbate 20	POLYSORBATE 20	7T1F30V5YH	INJECTION / INTRAMUSCULAR	1.62 %w/v		Exact identifier — unii candidate 28 equally ranked IID candidates
polysorbate 20	POLYSORBATE 20	7T1F30V5YH	LOTION / TOPICAL		2000 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
polysorbate 20	POLYSORBATE 20	7T1F30V5YH	INJECTION, SOLUTION / INTRAVENOUS		30 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
polysorbate 20	POLYSORBATE 20	7T1F30V5YH	CLOTH / TOPICAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	LOTION / TOPICAL	1 %w/w		Exact identifier — unii candidate 6 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	CREAM / TOPICAL		57 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
polysorbate 20	POLYSORBATE 20	7T1F30V5YH	EMULSION / TOPICAL	2 %w/w		Exact identifier — unii candidate 28 equally ranked IID candidates
polysorbate 20	POLYSORBATE 20	7T1F30V5YH	INJECTION / SUBCUTANEOUS	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
polysorbate 20	POLYSORBATE 20	7T1F30V5YH	SOLUTION / TOPICAL	15 %w/w		Exact identifier — unii candidate 28 equally ranked IID candidates
CARBOMER 1342	CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)	809Y72KV36	GEL / TRANSDERMAL		30 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	AEROSOL, FOAM / TOPICAL		72 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
polysorbate 20	POLYSORBATE 20	7T1F30V5YH	TAMPON / VAGINAL	64.8 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
CARBOMER 1342	CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)	809Y72KV36	LOTION / TOPICAL		29 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
polysorbate 20	POLYSORBATE 20	7T1F30V5YH	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
polysorbate 20	POLYSORBATE 20	7T1F30V5YH	TABLET, EXTENDED RELEASE / ORAL	4.2 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
CARBOMER 1342	CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)	809Y72KV36	GEL / TOPICAL		150 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
polysorbate 20	POLYSORBATE 20	7T1F30V5YH	GEL / TOPICAL	5 %w/w		Exact identifier — unii candidate 28 equally ranked IID candidates
polysorbate 20	POLYSORBATE 20	7T1F30V5YH	INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		60 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
polysorbate 20	POLYSORBATE 20	7T1F30V5YH	TABLET / ORAL		17 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
polysorbate 20	POLYSORBATE 20	7T1F30V5YH	CREAM / TOPICAL		108 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
polysorbate 20	POLYSORBATE 20	7T1F30V5YH	SUSPENSION / AURICULAR (OTIC)	0.1 %w/v		Exact identifier — unii candidate 28 equally ranked IID candidates
polysorbate 20	POLYSORBATE 20	7T1F30V5YH	SUSPENSION / ORAL		80 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	GEL / TOPICAL		14 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
polysorbate 20	POLYSORBATE 20	7T1F30V5YH	INJECTION, SOLUTION / SUBCUTANEOUS	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
polysorbate 20	POLYSORBATE 20	7T1F30V5YH	AEROSOL, FOAM / VAGINAL	3 %w/w		Exact identifier — unii candidate 28 equally ranked IID candidates
CARBOMER 1342	CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)	809Y72KV36	FILM, EXTENDED RELEASE / TRANSDERMAL	38.9 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
polysorbate 20	POLYSORBATE 20	7T1F30V5YH	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	CREAM, AUGMENTED / TOPICAL		10 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
polysorbate 20	POLYSORBATE 20	7T1F30V5YH	SOAP / TOPICAL	0.02 %w/w		Exact identifier — unii candidate 28 equally ranked IID candidates
CARBOMER 1342	CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)	809Y72KV36	CREAM / TOPICAL		2 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
polysorbate 20	POLYSORBATE 20	7T1F30V5YH	SHAMPOO / TOPICAL	8 %w/w		Exact identifier — unii candidate 28 equally ranked IID candidates
polysorbate 20	POLYSORBATE 20	7T1F30V5YH	SUSPENSION / OPHTHALMIC	0.05 %w/v		Exact identifier — unii candidate 28 equally ranked IID candidates
polysorbate 20	POLYSORBATE 20	7T1F30V5YH	POWDER, FOR SUSPENSION / ORAL	1.3 mg/5ml		Exact identifier — unii candidate 28 equally ranked IID candidates
CARBOMER 1342	CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)	809Y72KV36	EMULSION / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 6 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
8ce3d37a-9895-4d32-8185-7f24a5be1ad6			b2096fa2-f35d-44bb-b3cf-5ff877c0614c	2011-10-13	Warnings	Exact identifier spl id: 8ce3d37a-9895-4d32-8185-7f24a5be1ad6 spl set id: b2096fa2-f35d-44bb-b3cf-5ff877c0614c

Reported adverse events (FAERS/openFDA)#

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