UTASPRAY- menthol and methyl salicylate liquid

UtaSpray by

Drug Labeling and Warnings

UtaSpray 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

Menthol 10%

Methyl Salicylate 5%

Purpose

External analgesic

Uses

For temporary relief of joint and muscle aches and pains

• sprains and strains
• inflammation
• mild bruises

Warnings

For external use only

• Use only as directed
• Avoid contact with the eyes or mucous membranes
• Do not use on open wounds or irritated or broken skin
• Discontinue use if skin rash or irritation develops or if condition worsens
• Consult your doctor before use if you are pregnant or breastfeeding

• Keep out of reach of children

• Store at room temperature
• Shake well before use, close cap tightly after use
• Read all product information before use

Directions

• Clean and dry application area. Spray treatment directly onto skin and gently rub in if desired. May be used up to 10 times per day in adults and children over age 2.

Other Ingredients

Saposhnikoviae Radix, Artemisiae Argyi Folium, Moutan Cortex, Cimicfugae Rhizoma, Sophorae Flavescentis Radix, Paeoniae Radix, Rubra Notoginseng Radixet Rhizoma, Carthami Flos, Alcohol.

Principal Display Panel

INGREDIENTS AND APPEARANCE

UTASPRAY 
menthol and methyl salicylate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82198-0008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	100 mg  in 1 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SAPOSHNIKOVIA DIVARICATA ROOT (UNII: 8H84LFK2QD)
ARTEMISIA ARGYI LEAF (UNII: 2JYC99Q0WZ)
PAEONIA X SUFFRUTICOSA ROOT BARK (UNII: BUG255FE7X)
ACTAEA CIMICIFUGA ROOT (UNII: 65J267BAZT)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)
PANAX NOTOGINSENG ROOT (UNII: GQX1C1175U)
SAFFLOWER (UNII: 4VBL71TY4Y)
ALCOHOL (UNII: 3K9958V90M)

Product Characteristics
Color	brown (light brown)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82198-0008-1	70 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	10/01/2022

Labeler - Big 5 Nutrition LLC (114574559)

Establishment
Name	Address	ID/FEI	Business Operations
Taiwan Shuenn-Ann Biotechnology Pharmaceutical Co., Ltd.		656348265	manufacture(82198-0008)