Capsaicin Cream 0,025%

Manufacturer: AvPAK
Effective date: 2026-01-08
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-06-01 01:32:12

Label at a glance#

ProductCapsaicin External Analgesic

Active ingredientCAPSAICIN

Label structure11 sections

Indications and uses

temporarily relieves minor aches and pains of muscles and joints due to: simple backache arthritis strains sprains

Dosage and administration

Adults and children 18 years of age and older: apply a thin film of cream to affected area and gently rub in until fully absorbed unless treating hands, wash hands thoroughly with soap and water immediately after application for best results, apply 3 to 4 times daily. Children under 18 years: ask a doctor

Storage and handling

store at room temperature 15° - 30°C (59° - 86°F)

Contacts and useful links#

PhoneLabel contact1-855-361-3993

Websitewww.avkare.com

www.avkare.com

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Capsaicin 0.025%

Purpose

OTC - PURPOSE SECTION

External analgesic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves minor aches and pains of muscles and joints due to:

simple backache
arthritis
strains
sprains

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

For external use only

Read all warnings and directions before use. Test first on small area of skin.

Do not use

on wounds or damaged skin
if you are allergic to capsicum or chili peppers
with heating pad

When using this product

OTC - WHEN USING SECTION

you may experience a burning sensation. The intensity of this reaction varies among individuals and may be severe. With regular use, this sensation generally disappears after several days.
avoid contact with the eyes, lips, nose and mucous membranes
do not tightly wrap or bandage the treated area
do not apply heat to the treated area immediately before or after use

Stop use and ask a doctor if

OTC - STOP USE SECTION

condition worsens or does not improve after regular use
severe burning persists
redness or blistering occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 18 years of age and older:

apply a thin film of cream to affected area and gently rub in until fully absorbed
unless treating hands, wash hands thoroughly with soap and water immediately after application
for best results, apply 3 to 4 times daily.

Children under 18 years: ask a doctor

Other information

STORAGE AND HANDLING SECTION

store at room temperature 15° - 30°C (59° - 86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe barbadensis leaf extract, cetyl alcohol, glyceryl stearate SE, mineral oil, PEG-100 stearate, peppermint oil, phenoxyethanol, propylene glycol, purified water, stearyl alcohol, white petrolatum, xanthan gum

Questions or comments?

OTC - QUESTIONS SECTION

1-855-361-3993

SPL UNCLASSIFIED SECTION

Manufactured for:
AvKARE, Pulaski, TN 38478

www.avkare.com

AV 06/22

PRINCIPAL DISPLAY PANEL - 60 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
198555	capsaicin 0.025 % Topical Cream	PSN	4
198555	capsaicin 0.25 MG/ML Topical Cream	SCD	4
198555	capsaicin 0.025 % Topical Cream	SY	4

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50268-195-60	CapsaicinExternal Analgesic	1 in 1 CARTON	CREAM	1		4
50268-195-60	CapsaicinExternal Analgesic	60 g in 1 TUBE	CREAM	60		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50268-195-60	GM - Gram	50268-195	0d21324e-f0a0-4603-92e8-ad7501414457	1	2023-01-09

Products#

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

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

Capsaicin External Analgesic
Capsaicin
GLYCERYL STEARATE SE
CETYL ALCOHOL
PHENOXYETHANOL
GLYCERYL STEARATE/PEG-100 STEARATE
PETROLATUM
STEARYL ALCOHOL
XANTHAN GUM
PEPPERMINT OIL
ALOE VERA LEAF
MINERAL OIL
PROPYLENE GLYCOL
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
50268-195	50268-195-60

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
GLYCERYL STEARATE SE	FCZ5MH785I	IACT
CETYL ALCOHOL	936JST6JCN	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT
GLYCERYL STEARATE/PEG-100 STEARATE	RD25J5V947	IACT
PETROLATUM	4T6H12BN9U	IACT
STEARYL ALCOHOL	2KR89I4H1Y	IACT
XANTHAN GUM	TTV12P4NEE	IACT
PEPPERMINT OIL	AV092KU4JH	IACT
ALOE VERA LEAF	ZY81Z83H0X	IACT
MINERAL OIL	T5L8T28FGP	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
WATER	059QF0KO0R	IACT
CAPSAICIN	S07O44R1ZM	ACTIB

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
Capsaicin External Analgesic	CAPSAICIN	AvPAK	ef5a3846-1d2f-7023-e053-2a95a90ad716	2026-01-08	Warnings	Exact identifier ndc (package): 50268-195-60 ndc (product): 50268-195 ndc11 (package): 50268019560 spl id: 47e30136-9a43-81c5-e063-6394a90a3fbc spl set id: ef5a3846-1d2f-7023-e053-2a95a90ad716

Reported adverse events (FAERS/openFDA)#

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