SANAR - ARNICA ROLL ON- camphor gel

SANAR - ARNICA ROLL ON by

Drug Labeling and Warnings

SANAR - ARNICA ROLL ON by is a Otc medication manufactured, distributed, or labeled by SANVALL ENTERPRISES, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Camphor 1%

PURPOSE

Pain Relieving

Uses:

Aid for temporary local relief of minor pain in muscles or joints.

WARNINGS

For external use only. Avoid contact with eyes.

DO NOT USE

Use on wounds or damaged skin bandage tightly.

Stop use and consult a doctor if

condition worsens, or if symptoms persist for more than 7 days or clear up and occur again.

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

Adults and Children over 12 years: Apply generously to affected area. Massage until thoroughly absorbed.Repeat as necessary, but not more than 3 times daily. Children under 12 years: Consult a doctor.

OTHER SAFETY INFORMATION

Store tightly closed in a dry place at controlled room temperature between 59°-77° F (15°-25° C). Processed under the highest standards of quality assurance and Good Manufacturing Practices

INACTIVE INGREDIENT

Aqua, Ceteareth-25, Arnica Montana Flower Extract, Alcohol Denat, Menthol, Glycerin, Triethanolamine, Methyl Salicylate, Carbomer, Eucalyptus Globulus Leaf Oil, Disodium EDTA, Tocopheryl Acetate, Capsicum Annuum Fruit Extract, Methylchloroisothiazolinone, Methylisothiazolinone.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SANAR - ARNICA ROLL ON 
camphor gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73386-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CAPSICUM (UNII: 00UK7646FG)
ALCOHOL (UNII: 3K9958V90M)
METHYL SALICYLATE (UNII: LAV5U5022Y)
CARBOMER 940 (UNII: 4Q93RCW27E)
MENTHOL (UNII: L7T10EIP3A)
GLYCERIN (UNII: PDC6A3C0OX)
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)
WATER (UNII: 059QF0KO0R)
CETEARETH-25 (UNII: 8FA93U5T67)
TROLAMINE (UNII: 9O3K93S3TK)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73386-005-03	88.5 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/27/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	09/27/2021

Labeler - SANVALL ENTERPRISES, INC (966905507)