SANAR NATURAL-ARNICA ROLL ON ARNICA PAIN RELIEVING WITH CAMPHOR- evi labs cream

SANAR NATURAL-ARNICA ROLL ON by

Drug Labeling and Warnings

SANAR NATURAL-ARNICA ROLL ON by is a Otc medication manufactured, distributed, or labeled by EVI LABS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Camphor 1%

Purpose

Pain Relief

Uses

For the temporary relief of minor aches and pains of muscles and joints.

Warnings

For external use only. Avoid contact with eyes

Warnings

• Do not use on wounds or damaged skin
• Do not bandage tightly

Stop use and cosult a doctor

Stop use and cosult a doctor if condition worsens, or if symptoms persist for more than 7 days or dear up and occur again.

Keep out of reach of children

Keep out of reach of children: if swallowed, get medical help or contact Poison Control Center right away.

Directions

Directions: Adults and Children over 12 years Apply to affected area not more than 3 or 4 times daily. Childen under 12 years Do not use, consult a Doctor.

Other Information

Store tightly dosed in a dry place at a controlled room temperature between 59º- 77ºF ( 15º-25ºC).

Inactive Ingredient

Inactive Ingredient: Aqua, Arnica Montana Flower Extract, Propylene Glycol, Menthol, Glycerin, Carbomer, Methyl Salicylate, Triethanolamine, Eucalyptus Globulus Leaf Oil, Disodium EDTA, Tocopheryl Acetate, Capsicum Ammum Fruit Extract, Methylchloroisothiazolinone, Methylisothiazolinone.

Dosage & Administration

Apply to the affected area not more than 3 or 4 times daily.

Drug Facts

Principal Display Panel: Drug Facts.

INGREDIENTS AND APPEARANCE

SANAR NATURAL-ARNICA ROLL ON  ARNICA PAIN RELIEVING WITH CAMPHOR
evi labs cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84178-010
Route of Administration	CUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	0.885 g  in 88.5 g

Inactive Ingredients
Ingredient Name	Strength
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)	0.885 g  in 88.5 g
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)	0.35 g  in 88.5 g
GLYCERIN (UNII: PDC6A3C0OX)	2.655 g  in 88.5 g
MINERAL OIL (UNII: T5L8T28FGP)	1.77 g  in 88.5 g
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	0.885 g  in 88.5 g
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)	0.044 g  in 88.5 g
CAPSICUM ANNUUM WHOLE (UNII: 7FKZ3QQQ1F)	0.885 g  in 88.5 g
WATER (UNII: 059QF0KO0R)	69.005 g  in 88.5 g
TRIETHANOLAMINE (UNII: 9O3K93S3TK)	0.03 g  in 88.5 g
CARBOMER 940 (UNII: 4Q93RCW27E)	0.443 g  in 88.5 g
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)	0.235 g  in 88.5 g
CETEARYL ALCOHOL (UNII: 2DMT128M1S)	2.655 g  in 88.5 g
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)	0.885 g  in 88.5 g
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)	1.77 g  in 88.5 g
MENTHOL (UNII: L7T10EIP3A)	0.885 g  in 88.5 g
METHYL SALICYLATE (UNII: LAV5U5022Y)	3.9825 g  in 88.5 g
EDETATE DISODIUM (UNII: 7FLD91C86K)	0.177 g  in 88.5 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84178-010-01	88.5 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	01/23/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	01/23/2025

Labeler - EVI LABS (123617598)

Establishment
Name	Address	ID/FEI	Business Operations
EVI LABS		123617598	manufacture(84178-010)