ACTIBEAU SPORTS MASSAGE- niacinamide, adenosine gel 
ACTIVEBEUTY CO.,LTD.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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73016-002

Menthol 3.5%

Camphor 0.5%


Topical Analgesic

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

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.


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

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

image description

ACTIBEAU SPORTS MASSAGE 
niacinamide, adenosine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73016-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM4.2 g  in 120 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)0.6 g  in 120 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73016-002-021 in 1 CARTON04/01/2019
1NDC:73016-002-01120 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/01/2019
Labeler - ACTIVEBEUTY CO.,LTD. (695911007)
Registrant - ACTIVEBEUTY CO.,LTD. (695911007)
Establishment
NameAddressID/FEIBusiness Operations
JJindustry.Co.Ltd689605084manufacture(73016-002)

Revised: 4/2019
Document Id: 857c3301-6fd4-474e-e053-2991aa0a4f89
Set id: 577de624-1af3-47fe-895c-4775bdb2b490
Version: 1
Effective Time: 20190401
 
ACTIVEBEUTY CO.,LTD.