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NDC 72569-0760-03 KELVIN PRO Pain Relief Roll On 30; 120 mg/mL; mg/mL Details

KELVIN PRO Pain Relief Roll On 30; 120 mg/mL; mg/mL

KELVIN PRO Pain Relief Roll On is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by US Cosmetics, Inc. The primary component is CAMPHOR (SYNTHETIC); METHYL SALICYLATE.

Product Information

NDC	72569-0760
Product ID	72569-760_7ab5dccb-c571-3d10-e053-2991aa0a422c
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	KELVIN PRO Pain Relief Roll On
Proprietary Name Suffix	n/a
Non-Proprietary Name	METHYL SALICYLATE, AMOMUM TESTACEUM SEED
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	30; 120
Active Ingredient Units	mg/mL; mg/mL
Substance Name	CAMPHOR (SYNTHETIC); METHYL SALICYLATE
Labeler Name	US Cosmetics, Inc
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2022-12-31

Package

Package Images

NDC 72569-0760-03 (72569076003)

Pricing Information	N/A
NDC Package Code	72569-760-03
Billing NDC	72569076003
Package	89 mL in 1 BOTTLE (72569-760-03)
Marketing Start Date	2018-09-10
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 9cb6dfd1-c655-46dc-b4d4-5c2b8a2e42aa Details

Drug Facts

Active Ingredient:

Methyl Salicylate 12%

Camphor 3%

Purpose:

Topical Analgesic

Indications:

For the temporary relief of minor aches and pains of the muscles and joints associated with arthritis, simple backache, sprains, bruises and strains.

Warnings:

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 apply to wounds or damaged skin.
Do not bandage tightly.

If pregnant or breast feeding,

contact physician prior to use.

Directions:

Adults and children two-years of age or older: Apply to affected area not more than three to four times daily.
Children under two-years of age: consult a physician.

Additional Information:

Store at room temperature.

Other Ingredients:

Acrylates Copolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Ethylhexylglycerin, Helianthus Annuus (Sunflower) Oil, Isopropyl Myristate, Magnesium Sulfate, Phenoxyethanol, Sodium Lauryl Sulfate, Triethanolamine.

Package Labeling:

INGREDIENTS AND APPEARANCE

KELVIN PRO PAIN RELIEF ROLL ON

methyl salicylate, amomum testaceum seed liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72569-760
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	120 mg in 1 mL
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	30 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TROLAMINE (UNII: 9O3K93S3TK)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72569-760-03	89 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/10/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	09/10/2018

Labeler - US Cosmetics, Inc (081369740)

Revised: 11/2018

Document Id: 7ab5dccb-c571-3d10-e053-2991aa0a422c

Set id: 9cb6dfd1-c655-46dc-b4d4-5c2b8a2e42aa

Version: 2

Effective Time: 20181115

Search by Drug Name or NDC

NDC 72569-0760-03 KELVIN PRO Pain Relief Roll On 30; 120 mg/mL; mg/mL Details

KELVIN PRO Pain Relief Roll On 30; 120 mg/mL; mg/mL

Product Information

Package

Package Images

NDC 72569-0760-03 (72569076003)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 9cb6dfd1-c655-46dc-b4d4-5c2b8a2e42aa Details

Drug Facts

Active Ingredient:

Purpose:

Indications:

Warnings:

Do not apply

Keep out of reach of children.

If pregnant or breast feeding,

Directions:

Additional Information:

Other Ingredients:

Package Labeling:

INGREDIENTS AND APPEARANCE

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Search by Drug Name or NDC

NDC 72569-0760-03 KELVIN PRO Pain Relief Roll On 30; 120 mg/mL; mg/mL Details

KELVIN PRO Pain Relief Roll On 30; 120 mg/mL; mg/mL

Product Information

Package

Package Images

NDC 72569-0760-03 (72569076003)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 9cb6dfd1-c655-46dc-b4d4-5c2b8a2e42aa Details

Drug Facts

Active Ingredient:

Purpose:

Indications:

Warnings:

Do not apply

Keep out of reach of children.

If pregnant or breast feeding,

Directions:

﻿Additional Information:

Other Ingredients:

Package Labeling:

INGREDIENTS AND APPEARANCE

Additional Information: