ACTIBEAU SPORTS MASSAGE- niacinamide, adenosine gel

United States - English - NLM (National Library of Medicine)

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Active ingredient:
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A), CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)
Available from:
ACTIVEBEUTY CO.,LTD.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Topical Analgesic For temporary relief of minor aches and pains of muscles and joints associated with • simple backache • arthritis • strains• bruises • sprains
Authorization status:
OTC monograph not final
Authorization number:
73016-002-01, 73016-002-02

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.

----------

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

ACTIBEAU SPORTS MASSAGE

niacinamide, adenosine gel

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:730 16 -0 0 2

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

MENTHO L, UNSPECIFIED FO RM (UNII: L7T10 EIP3A) (MENTHOL - UNII:L7T10 EIP3A)

MENTHOL, UNSPECIFIED

FORM

4.2 g

in 120 g

CAMPHO R ( SYNTHETIC) (UNII: 5TJD8 2A1ET) (CAMPHOR (SYNTHETIC) -

UNII:5TJD8 2A1ET)

CAMPHOR (SYNTHETIC)

0 .6 g

in 120 g

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

ISO PRO PYL ALCO HO L (UNII: ND2M416 30 2)

GLYCERIN (UNII: PDC6 A3C0 OX)

GLYCYRRHIZA GLABRA (UNII: 278 8 Z9 758 H)

DIMETHYL SULFO NE (UNII: 9 H4PO4Z4FT)

CARBO XYPO LYMETHYLENE (UNII: 0 A5MM30 7FC)

PEG-6 0 HYDRO GENATED CASTO R O IL (UNII: 0 2NG325BQG)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I)

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:730 16 -0 0 2-0 2

1 in 1 CARTON

0 4/0 1/20 19

1

NDC:730 16 -0 0 2-0 1

120 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt348

0 4/0 1/20 19

Labeler -

ACT IVEBEUT Y CO.,LT D. (695911007)

Registrant -

ACT IVEBEUT Y CO.,LT D. (695911007)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

JJindustry.Co .Ltd

6 8 9 6 0 50 8 4

ma nufa c ture (730 16 -0 0 2)

ACTIVEBEUTY CO.,LTD.

Revised: 4/2019

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