Painfix Relief Gel

Painfix Relief Gel
SPL v4
SPL
SPL Set ID 4320db2b-69d0-421b-9890-eeb8c40318ec
Route
TOPICAL
Published
Effective Date 2023-12-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (50 mg)
Inactive Ingredients
Aloe Vera Leaf Water Arnica Montana Flower Bambusa Vulgaris Sap Shea Butter Medium-chain Triglycerides Caprylyl Glycol Carbomer Homopolymer, Unspecified Type Polyoxyl 20 Cetostearyl Ether Cetostearyl Alcohol Cetyl Alcohol Chinese Cinnamon Oil Orange Oil, Cold Pressed Myrrh Turmeric Glycerin Glyceryl Laurate Glyceryl 1-undecylenate Ilex Paraguariensis Leaf Magnesium Sulfate, Unspecified Form Dimethyl Sulfone Polysorbate 20 Propylene Glycol Rhubarb Scutellaria Baicalensis Root Sesame Oil Sodium Hydroxide Sorbic Acid Xanthan Gum Ginger

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2019-02-01 Until 2022-11-30

Description

Menthol 5%

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

Menthol 5%

Uses

temporarily relieves aches and pains of joints and muscles associated with • backache • arthritis • cramps • strains • bruises • sprains

Section 42229-5

YOU GOT THIS

Plant-Based

www.painfixbody.com

Made in USA

Manufactured for:

PainFix LLC

Brooklyn, NY 11201

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Warnings

Avoid direct contact with eyes.

For external use only.

When using this product • use only as directed • avoid contact with eyes or mucous membranes • do not apply local heat to the area of use • do not apply to wounds, broken, damaged or irritated skin

Stop use and ask a doctor if • condition worsens or symptoms persist for more than 7 days • skin irritation develops or you experience signs of skin injury, such as pain, swelling, or blistering where product is applied

If pregnant or breast-feeding, ask a health professional before use.

Packaging

Directions

Adults and children above 12 years:

  • apply gel to affected area(s) and massage gently until thoroughly absorbed into skin
  • repeat up to 3 to 4 times per day, on an as needed basis
  • after applying, wash hands with soap and water

Children 12 years and younger, ask a health professional

Ingredients

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Bambusa Vulgaris (Mastic) Sap Extract, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Caprylyl Glycol, Carbomer, Ceteareth-20, Cetearyl Alcohol, Cetyl Alcohol, Cinnamomum Cassia Oil, Citrus Aurantium Dulcis (Orange) Extract, Commiphora Myrrha (Myrrh) Extract, Curcuma Longa (Turmeric) Extract, Glycerin, Glyceryl Laurate, Glyceryl Undecylenate, Ilex Paraguariensis (Yerba Mate) Extract, Magnesium Sulfate, MethylSulfonylmethane (MSM), Polysorbate-20, Propylene Glycol, Rheum Palmatum (Rhubarb) Extract, Scutellaria Baicalensis (Skullcap) Extract, Sesamum Indicum (Sesame) Oil, Sodium Hydroxide, Sorbic Acid, Xanthan Gum, Zingiber Officinale (Ginger) Extract

Other Information

• store in a cool, dry place, away from direct sunlight

Active Ingredients

Menthol 5%


Structured Label Content

Uses

temporarily relieves aches and pains of joints and muscles associated with • backache • arthritis • cramps • strains • bruises • sprains

Section 42229-5 (42229-5)

YOU GOT THIS

Plant-Based

www.painfixbody.com

Made in USA

Manufactured for:

PainFix LLC

Brooklyn, NY 11201

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Purpose

Topical analgesic

Warnings

Avoid direct contact with eyes.

For external use only.

When using this product • use only as directed • avoid contact with eyes or mucous membranes • do not apply local heat to the area of use • do not apply to wounds, broken, damaged or irritated skin

Stop use and ask a doctor if • condition worsens or symptoms persist for more than 7 days • skin irritation develops or you experience signs of skin injury, such as pain, swelling, or blistering where product is applied

If pregnant or breast-feeding, ask a health professional before use.

Packaging

Directions

Adults and children above 12 years:

  • apply gel to affected area(s) and massage gently until thoroughly absorbed into skin
  • repeat up to 3 to 4 times per day, on an as needed basis
  • after applying, wash hands with soap and water

Children 12 years and younger, ask a health professional

Ingredients

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Bambusa Vulgaris (Mastic) Sap Extract, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Caprylyl Glycol, Carbomer, Ceteareth-20, Cetearyl Alcohol, Cetyl Alcohol, Cinnamomum Cassia Oil, Citrus Aurantium Dulcis (Orange) Extract, Commiphora Myrrha (Myrrh) Extract, Curcuma Longa (Turmeric) Extract, Glycerin, Glyceryl Laurate, Glyceryl Undecylenate, Ilex Paraguariensis (Yerba Mate) Extract, Magnesium Sulfate, MethylSulfonylmethane (MSM), Polysorbate-20, Propylene Glycol, Rheum Palmatum (Rhubarb) Extract, Scutellaria Baicalensis (Skullcap) Extract, Sesamum Indicum (Sesame) Oil, Sodium Hydroxide, Sorbic Acid, Xanthan Gum, Zingiber Officinale (Ginger) Extract

Other Information

• store in a cool, dry place, away from direct sunlight

Active Ingredients

Menthol 5%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)