Jointflex Nighttime Pain Relief

Jointflex Nighttime Pain Relief
SPL v4
SPL
SPL Set ID cb5ca02b-0bc1-4b0b-b4b1-abef3222aa56
Route
TOPICAL
Published
Effective Date 2023-01-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (synthetic) (3.2 g)
Inactive Ingredients
Acetylated Lanolin Alkyl (c12-15) Benzoate Aloe Vera Leaf Alpha-tocopherol Acetate Carbomer 1342 Carbomer Interpolymer Type A (55000 Cps) Chondroitin Sulfate (shark) Diazolidinyl Urea Dimethicone Edetate Disodium Glucosamine Sulfate Potassium Chloride Glycerin Glyceryl Monostearate Hydroxylated Lanolin Hypromelloses Iodopropynyl Butylcarbamate Methyl Gluceth-20 Methyl Glucose Sesquistearate Panthenol Peppermint Oil Polyoxyl 40 Stearate Polysorbate 20 Potassium Hydroxide Shark Cartilage Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-06-01

Description

Camphor (3.2%)

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

Camphor (3.2%)

Uses:

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
Directions:

Rotate the massager head to ON position and squeeze tube gently to dispense. Return the massager head to OFF position. Using a circular pattern, gently massage over the pain inflicted area using the built-in roller balls until the Emulsion Gel disappears.

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® Night Time Pain Relief Emulsion Gel 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
Active Ingredient

Camphor (3.2%)

Other Information:
  • store at room temperature with the cap closed
  • notice: because this product contains natural ingredients, 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, Fragrance, Glucosamine Sulfate, Glycerin, Glycerol Stearate, Glycosaminoglycans, Hydroxylated Lanolin, Hydroxpropyl Methycellulose, Iodopropynyl Butylcarbamate, Methyl Gluceth-20, Methyl Glucose Sesquistearate, Peppermint Oil, Polysorbate 20, Potassium Carbomer, Purified Water, Tocopheryl Acetate (Vitamin E).

Questions Or Comments?

Call (866) 235-4581 or email [email protected]

Manufactured for

Strides Consumer LLC,

East Brunswick, NJ 08816

Licensed user of trademarks. ©2022 Strides Consumer LLC

†Results based on a 2021 Healthcare Provider survey conducted by InStep Health as part of a point-of-care marketing campaign sponsored by Strides Consumer LLC.

www.jointflex.com

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.

Ask A Doctor Befor Use If You Have
  • redness over the affected area
Package Label.principal Display Panel

Flex Your FreedomTM

Visit www.jointflex.com for more information

DEEP PENETRATING Fusome ® Technology

Quick & effective penetration

Targeted pain relief

Long lasting relief when used daily

Roller-Flex TM Massager gently works to reduce pain right at the source

Roller-FlexTMMassager

Innovative Massage Applicator

#1 CLINICALLY RECOMMENDED JOINT PAIN CREAM

Effectively Reduces Joint Pain

Immediate & Long Lasting Relief*

Relaxing** Lavender DreamScentTM

Contains Glucosamine & Chondroitin for skin conditioning

NDC 72927-976-02

NET WT 3.5 OZ (99g)

Night Time Pain Relief

Back, Neck & Shoulde

Knee & Elbow

Foot, Ankle, Leg

Hand & Wrist

*When applied as directed

**fragrance technology validated using Sandman Classifier Test

Roller-FlexTMMassager

5 Stainless steel rollerballs

Deep pressure massage applicator

Cool to the touch

Targeted pain relief

Night Time Pain Relief Emulsion Gel

TUBES ARE FILLED BY WEIGHT NOT VOLUME

011-1650C-R01


Structured Label Content

Uses:

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

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
Purpose

Topical analgesic

Warnings:

For external use only.

Do Not Use (Do not use)
  • if skin is irritated or damaged
  • excessive irritation develops
  • 12 years of age or under
Directions:

Rotate the massager head to ON position and squeeze tube gently to dispense. Return the massager head to OFF position. Using a circular pattern, gently massage over the pain inflicted area using the built-in roller balls until the Emulsion Gel disappears.

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® Night Time Pain Relief Emulsion Gel 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
Active Ingredient (Active ingredient)

Camphor (3.2%)

Other Information: (Other information:)
  • store at room temperature with the cap closed
  • notice: because this product contains natural ingredients, color may vary
Inactive Ingredients: (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, Fragrance, Glucosamine Sulfate, Glycerin, Glycerol Stearate, Glycosaminoglycans, Hydroxylated Lanolin, Hydroxpropyl Methycellulose, Iodopropynyl Butylcarbamate, Methyl Gluceth-20, Methyl Glucose Sesquistearate, Peppermint Oil, Polysorbate 20, Potassium Carbomer, Purified Water, Tocopheryl Acetate (Vitamin E).

Questions Or Comments? (Questions or comments?)

Call (866) 235-4581 or email [email protected]

Manufactured for

Strides Consumer LLC,

East Brunswick, NJ 08816

Licensed user of trademarks. ©2022 Strides Consumer LLC

†Results based on a 2021 Healthcare Provider survey conducted by InStep Health as part of a point-of-care marketing campaign sponsored by Strides Consumer LLC.

www.jointflex.com

When Using This Product (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 (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. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.

Ask A Doctor Befor Use If You Have (Ask a doctor befor use if you have)
  • redness over the affected area
Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

Flex Your FreedomTM

Visit www.jointflex.com for more information

DEEP PENETRATING Fusome ® Technology

Quick & effective penetration

Targeted pain relief

Long lasting relief when used daily

Roller-Flex TM Massager gently works to reduce pain right at the source

Roller-FlexTMMassager

Innovative Massage Applicator

#1 CLINICALLY RECOMMENDED JOINT PAIN CREAM

Effectively Reduces Joint Pain

Immediate & Long Lasting Relief*

Relaxing** Lavender DreamScentTM

Contains Glucosamine & Chondroitin for skin conditioning

NDC 72927-976-02

NET WT 3.5 OZ (99g)

Night Time Pain Relief

Back, Neck & Shoulde

Knee & Elbow

Foot, Ankle, Leg

Hand & Wrist

*When applied as directed

**fragrance technology validated using Sandman Classifier Test

Roller-FlexTMMassager

5 Stainless steel rollerballs

Deep pressure massage applicator

Cool to the touch

Targeted pain relief

Night Time Pain Relief Emulsion Gel

TUBES ARE FILLED BY WEIGHT NOT VOLUME

011-1650C-R01


Advanced Ingredient Data


Raw Label Data

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