ACTIBEAU SPORTS MASSAGE- niacinamide, adenosine gel

ACTIBEAU Sports Massage by

Drug Labeling and Warnings

ACTIBEAU Sports Massage by is a Otc medication manufactured, distributed, or labeled by ACTIVEBEUTY CO.,LTD., JJindustry.Co.Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Menthol 3.5%

Camphor 0.5%

PURPOSE

Topical Analgesic

INDICATIONS & USAGE

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

DOSAGE & ADMINISTRATION

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.

WARNINGS

For external use only

Flammable keep away from fire or flame

When using this product, avoid contact with eyes or mucous membranes do not bandage tightly do not apply to wound or damaged or irritated skin

Stop use and consult a doctor if condition worsens symptoms persist for more than 7 days clear up and occur again within a few days
If pregnant or breast-feeding, ask a health professional before use

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

INACTIVE INGREDIENT

Water, Isopropyl Alcohol, Glycerin, Glycyrrhiza Glabra Root Extract, Methyl sulfonyl methane, Carbomer, PEG-60 Hydrogenated Caster Oil, Methylparaben, Sodium Hydroxide, FD&C blue No. 1, Flavoring

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ACTIBEAU SPORTS MASSAGE 
niacinamide, adenosine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73016-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	4.2 g  in 120 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	0.6 g  in 120 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)
METHYLPARABEN (UNII: A2I8C7HI9T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73016-002-02	1 in 1 CARTON	04/01/2019
1	NDC: 73016-002-01	120 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	04/01/2019

Labeler - ACTIVEBEUTY CO.,LTD. (695911007)

Registrant - ACTIVEBEUTY CO.,LTD. (695911007)

Establishment
Name	Address	ID/FEI	Business Operations
JJindustry.Co.Ltd		689605084	manufacture(73016-002)