Ultra strength pain relief balm

Manufacturer: Velocity Pharma LLC
Effective date: 2022-11-20
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 23:51:43

Label at a glance#

ProductUltra strength pain relief balm Ultra Strength

Active ingredientCAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM

Label structure9 sections

Indications and uses

See outer packaging for full uses.

Dosage and administration

For adults and children over 12, rub well on the affected area. Repeat 3 to 4 times daily For children 12 years of age or younger, consult a doctor before use.

Storage and handling

This product may cause allergic reaction on some individuals. Test on small area before use.

Contacts and useful links#

PhoneLabel contact1-855-314-1850

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active Ingredients	Purpose
Camphor 11%	Topical Analgesic
Menthol 11%	Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

See outer packaging for full uses.

Warnings

WARNINGS SECTION

For External Use Only

When using this product

OTC - WHEN USING SECTION

Use only as directed
Avoid contact with eyes and mucous membranes
Do not apply to wounds, damaged or irritated skin
Do not bandage or cover with wrap or use heating pad
Do not use 1 hour prior to bathing or within 30 minutes after bathing.

Stop use and ask a doctor if

OTC - STOP USE SECTION

Condition worsens
Severe skin irritation occurs
Pain persists for more than 7 days
Pain clears up and then recurs a few days later.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, or if you have sensitive skin, ask a healthcare professional before use.

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

For adults and children over 12, rub well on the affected area. Repeat 3 to 4 times daily
For children 12 years of age or younger, consult a doctor before use.

Other information

STORAGE AND HANDLING SECTION

This product may cause allergic reaction on some individuals. Test on small area before use.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Cajuput Oil, Cassia Oil, Clove Oil, Dementholized Mint Oil and Paraffin base.

Questions

OTC - QUESTIONS SECTION

1-855-314-1850

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

bam1bam2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1089847	camphor 11 % / menthol 11 % Topical Ointment	PSN	3
1089847	camphor 0.11 MG/MG / menthol 0.11 MG/MG Topical Ointment	SCD	3
1089847	camphor 11 % / menthol 11 % Topical Ointment	SY	3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
76168-331-18	2024-01-30	C162847	48780-1	d6a99b39-fb52-a426-e053-dadaa90af4c2	Ultra strength pain relief balm
76168-331-18	2022-11-21	C162847	48780-1	d6a99b39-fb52-a426-e053-dadaa90af4c2	Ultra strength pain relief balm
76168-331-18	2022-01-28	C162847	48780-1	d6a99b39-fb52-a426-e053-dadaa90af4c2	Ultra strength pain relief balm

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76168-331-18	Ultra strength pain relief balmUltra Strength	18 g in 1 JAR	OINTMENT	18		3
76168-331-18	Ultra strength pain relief balmUltra Strength	1 in 1 PACKAGE	OINTMENT	1		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76168-331	ULTRA STRENGTH PAIN RELIEF BALM ULTRA STRENGTH (CAMPHOR (SYNTHETIC) AND MENTHOL) OINTMENT [VELOCITY PHARMA LLC]	3	Legacy NDC, 2 package rows	20221122_5f791159-c388-4c77-8aca-35e4c3f7cacd.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

Ultra strength pain relief balm Ultra Strength
Camphor (Synthetic) and Menthol
CAJUPUT OIL
PADANG CASSIA OIL
CLOVE OIL
CAMPHOR (SYNTHETIC)
MENTHOL, UNSPECIFIED FORM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
76168-331	76168-331-18

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CAJUPUT OIL	J3TO6BUQ37	IACT
PADANG CASSIA OIL	0E15252LIW	IACT
CLOVE OIL	578389D6D0	IACT
CAMPHOR (SYNTHETIC)	5TJD82A1ET	ACTIB
MENTHOL, UNSPECIFIED FORM	L7T10EIP3A	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
edf30b05-987d-b701-e053-2a95a90a9849			5f791159-c388-4c77-8aca-35e4c3f7cacd	2022-11-20	Warnings	Exact identifier spl id: edf30b05-987d-b701-e053-2a95a90a9849 spl set id: 5f791159-c388-4c77-8aca-35e4c3f7cacd

Reported adverse events (FAERS/openFDA)#

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