TOP MEDICATED OIL- camphor, menthol, methyl salicylate oil

Top Medicated Oil by

Drug Labeling and Warnings

Top Medicated Oil by is a Otc medication manufactured, distributed, or labeled by Big 5 Nutrition LLC, Taiwan Shuenn-Ann Biotechnology Pharmaceutical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Camphor 10%

Menthol 16%

Methyl Salicylate 40%

Purpose

External Analgesic

Uses

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

simple backache arthritis  strains bruises sprains 

Warnings

For external use only

Do not use

on wounds

on irritated or damaged skin

otherwise than as directed

When using this product

avoid contact with the eyes or mucous membranes

do not bandage tightly

Stop use and ask a doctor if

condition worsens  symptoms persist for more than 7 days

symptoms clear up and occur again within a few days

excessive irritation of the skin develops

nausea, vomiting, abdominal discomfort, diarrhea, or skin rashes occurs

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

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

Directions

adults and children 12 years of age and older: apply 3 to 4 drops of medicated oil to the affected area 1 to 2 times daily. After applying the product, a warm pad may be placed on the affected area for 10 minutes and then massage as shown in the illustrations. 

children under 12 years of age: consult your physician.

refer to the above warnings; use otherwise than as directed may be dangerous.

Other information

store at 16° to 30°C (61° to 86° F)  store in an airtight container

Inactive ingredients

Eucalyptus oil  Lavender oil

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY:

A&A MEDICAL SUPPLIES, INC.

S. El Monte, CA 91733 USA 

MADE IN TAIWAN

ITEM NO. HK105

Packaging

INGREDIENTS AND APPEARANCE

TOP MEDICATED OIL 
camphor, menthol, methyl salicylate oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82198-0009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	10 mg  in 1 mL
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	16 mg  in 1 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	40 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
EUCALYPTUS OIL (UNII: 2R04ONI662)
LAVENDER OIL (UNII: ZBP1YXW0H8)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82198-0009-1	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	01/01/2023

Labeler - Big 5 Nutrition LLC (114574559)

Establishment
Name	Address	ID/FEI	Business Operations
Taiwan Shuenn-Ann Biotechnology Pharmaceutical Co., Ltd.		656348265	manufacture(82198-0009)