JOINTFLEX- jointflex cream

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

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Active ingredient:
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)
Available from:
Strides Consumer LLC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Topical analgesic For the temporary relief of minor aches and pains of muscles and joints associated with: - simple backache - arthritis - strains - bruises - sprains - if skin is irritated or damaged - excessive irritation develops - 12 years of age or under - condition worsens - symptoms persist for more than 7 days or clear up and occur again within a few days - redness develops
Authorization status:
OTC monograph not final
Authorization number:
72927-904-01

JOINTFLEX- jointflex cream

Strides Consumer LLC

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.

----------

JointFlex®

Pain Relief Cream

Drug Facts

Actice Ingredient

Camphor (3.2%)

Purpos e

Topical analgesic

Us es :

For the temporary relief of minor aches and pains of muscles and joints associated with:

simple backache

arthritis

strains

bruises

sprains

Warnings :

For external use only.

Do not use

if skin is irritated or damaged

excessive irritation develops

12 years of age or under

When using this product

use only as directed

avoid contact with the eyes and mucous membranes

do not apply to wounds, damaged, broken or irritated skin

do not bandage tightly or use a heating pad

do not swallow.

Stop use and ask doctor if

condition worsens

symptoms persist for more than 7 days or clear up and occur again within a few days

redness develops

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:

clean, rinse and dry skin prior to

application

apply generously to painful muscles and

joints, gently massaging until the

JointFlex® Pain Relieving Cream

disappears.

repeat as necessary but no more than 4

times a day

for optimum benefit, use daily for at least

two weeks and continue to use daily

thereafter.

children under 12

years of age:

ask a doctor

Other information

store at room temperature with the cap closed

notice: because this product contains natural nutrients, color may vary

Inactive ingredients:

Acetylated Lanolin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Vera, C12-15 Alkyl

Benzoate, Chondroitin Sulfate, Diazolidinyl Urea, Dimethicone, Dimethiconol Stearate, Disodium

EDTA, dl Panthenol, Glucosamine Sulfate, Glycerin, Glycerol Stearate, Glycosaminoglycans,

Hydroxylated Lanolin, Hydroxpropylene methycellulose, Idopropynyl Butyl Carbamate, Methyl

Gluceth-20, Methyl Glucose Sesquistearate, Peppermint Oil, Polysorbate 20, Potassium Carbomer,

Purified Water, Tocopheryl Acetate (Vitamin E).

Questions and comments?

Call (866) 235-4581

Manufacture for

Strides Consumer LLC,

East Brunswick, NJ 08816

www.jointflex.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

8 Week Challenge for pain relief

100% Money Back Guarantee*

Effectively Reduces Joint Pain

JointFlex - Pain Relief Cream

Immediate & Long Lasting Relief*

Contains Glucosamine & Chondroitin**

No stain/ No Grease/ Pleasant Scent

DEEP PENETRATING Fusome* Technology

Quick & effective penetration

Targeted pain relief

Long lasting relief when used daily

Flex Your Freedom

Relieves Back, Neck, Shoulder, Knees, Elbow, Foot, Ankle, Leg Hand and Wrist pain

NET WT 4 OZ (114g)

JointFlex

GUARANTEE

"If you use JointFlex as directed and are not completely amazed with the pain relief you received,

simply return the tube (even if it's empty) and the cash register receipt to the address below for a full

refund. No questions asked."

Questions or comments?

Call (866)-235-4581.

Strides Consumer LLC,

East Brunswick, NJ 08816

NDC 72927-904-01

Visit www.jointflex.com for more information

JointFlex

is a registered trademark of Strides Global Consumer Pvt. Ltd.

Fusome is a registered trademark of SmartScience Laboratories, Inc.

© 2019 Strides Consumer LLC

* when applied as directed

** For skin conditioning

011-1605C-R00

®

®

Carton label

Tube label

JOINTFLEX

jointflex cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:729 27-9 0 4

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

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

UNII:5TJD8 2A1ET)

CAMPHOR

(SYNTHETIC)

3.2 g

in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

ALPHA-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )

ACETYLATED LANO LIN (UNII: 2X6 54GD19 H)

ALKYL ( C12 -15) BENZO ATE (UNII: A9 EJ3J6 1HQ)

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

CARBO MER 13 4 2 (UNII: 8 0 9 Y72KV36 )

CARBO MER INTERPO LYMER TYPE A ( 550 0 0 CPS) (UNII: 59 TL3WG5CO)

CHO NDRO ITIN SULFATE ( SHARK) (UNII: 2ZAJ1K50 XH)

DIAZO LIDINYL UREA (UNII: H5RIZ3MPW4)

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)

GLUCO SAMINE SULFATE PO TASSIUM CHLO RIDE (UNII: 15VQ11I6 6 N)

GLYCERIN (UNII: PDC6 A3C0 OX)

GLYCERYL MO NO STEARATE (UNII: 230 OU9 XXE4)

HYDRO XYLATED LANO LIN (UNII: EOI0 B9 8 0 0 C)

HYPRO MELLO SES (UNII: 3NXW29 V3WO)

IO DO PRO PYNYL BUTYLCARBAMATE (UNII: 6 0 3P14DHEB)

METHYL GLUCETH-2 0 (UNII: J3QD0 LD11P)

METHYL GLUCO SE SESQ UISTEARATE (UNII: V1YW10 H14D)

PANTHENO L (UNII: WV9 CM0 O6 7Z)

PEPPERMINT O IL (UNII: AV0 9 2KU4JH)

PO LYO XYL 4 0 STEARATE (UNII: 13A4J4NH9 I)

PO LYSO RBATE 2 0 (UNII: 7T1F30 V5YH)

PO TASSIUM HYDRO XIDE (UNII: WZH3C48 M4T)

SHARK CARTILAGE (UNII: D2YCN1I522)

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:729 27-9 0 4-0 1

1 in 1 CARTON

0 8 /0 2/20 19

1

114 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 8 /0 2/20 19

Labeler -

Strides Consumer LLC (116975770)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Beltapharm SPA

429 236 78 9

ANALYSIS(729 27-9 0 4) , MANUFACTURE(729 27-9 0 4) , PACK(729 27-9 0 4)

Strides Consumer LLC

Revised: 7/2019

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