Csi Menthol Overnight Relief Gel-patch, 5 Patches

Csi Menthol Overnight Relief Gel-patch, 5 Patches
SPL v5
SPL
SPL Set ID f1041b25-eb09-e43d-e053-2995a90a073a
Route
TOPICAL
Published
Effective Date 2024-12-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (0.001 g)
Inactive Ingredients
Kaolin Tartaric Acid Water Dihydroxyaluminum Aminoacetate Anhydrous Propylene Glycol Polyacrylic Acid (250000 Mw) Carboxymethylcellulose Sodium Sodium Polyacrylate (2500000 Mw) Titanium Dioxide Mineral Oil Petrolatum Benzalkonium Chloride Lauralkonium Chloride Polysorbate 80 Glycerin Povidone K90 Lavender Oil Edetate Disodium

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-12-30

Description

Menthol 5% w/w ...... Purpose: Topical analgesic

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

Menthol 5% w/w ...... Purpose: Topical analgesic

Uses

Temporarily relieves minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthrits
  • strains
  • bruises
  • sprains
Section 51945-4

Stop Use

Stop use and ask a doctor if : Burning disconfort or excessive skin irritation develops, condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days

Warnings

For external use only

When using this prudocts:

• use only as directed

• avoid contact with eyes or on mucous membranes

• do not apply to wounds or damaged skin

• do not apply to irritated skin or if excessive irritation develops

• do not bandage tightly or use with heating pad or device

Stop use and ask a doctor if:

• you experience pain, swelling or blistering of the skin

• condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days

• arthritic pain persists for more than 10 days, or redness is present

If pregnant or breastfeeding,ask a health professional before use.

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

Ask Doctor

Stop use and ask a doctor if:

• you experience pain, swelling or blistering of the skin

• condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days

• arthritic pain persists for more than 10 days, or redness is present

If pregnant or breastfeeding,ask a health professional before use.

Directions

• adults and children 12 years of age and older: Clean and dry affected area, pop apart and partially peel back protective film and apply exposed gel-patch to site of pain. Carefully remove remaining film while pressing the gel-patch to skin and leave in place for up to 8 hours. Use on affected areas not more than 3 to 4 times daily.

• children under 12 years of age: consult a physician

• wash hands after use with cool water

Do Not Use

• do not apply to wounds or damaged skin

• do not apply to irritated skin or if excessive irritation develops

• do not bandage tightly or use with heating pad or device

When Using

When using this prudocts:

• use only as directed

• avoid contact with eyes or on mucous membranes

• do not apply to wounds or damaged skin

• do not apply to irritated skin or if excessive irritation develops

• do not bandage tightly or use with heating pad or device

Active Ingredient

Menthol 5% w/w ...... Purpose: Topical analgesic

Other Information

• store at 20-25℃ (68-77℉)

• store in a cool dry place away from direct sunlight

Inactive Ingredients

Water, Glycerin, Polyacrylic Acid, Propylene Glycol, Sodium Polyacrylate, Mineral Oil, Lavender Essential Oil, Polysorbate 80, PVP, Petrolatum, Dihydroxyaluminum Aminoacetate, Edetate Disodium, Kaolin, Carboxymethylcellulose Sodium, Titanium Dioxide, L-Tartaric Acid, Benzalkonium Chloride, Lauralkonium Chloride

Questions Or Comments

Questions or comments : 86-21-31166566

Dosage Forms & Strengths

This is patch dosage form.

The active ingredient strength is 5%.

Pregnancy Or Breast Feeding

If pregnant or breastfeeding,ask a health professional before use.

Keep Out of Reach of Children

If accidentally ingested, get medical help or contact a Poison Control Center immediately

Package Label. Principal Display Panel


Structured Label Content

Uses

Temporarily relieves minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthrits
  • strains
  • bruises
  • sprains
Section 51945-4 (51945-4)

Purpose

Topical analgesic

Stop Use (Stop use)

Stop use and ask a doctor if : Burning disconfort or excessive skin irritation develops, condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days

Warnings

For external use only

When using this prudocts:

• use only as directed

• avoid contact with eyes or on mucous membranes

• do not apply to wounds or damaged skin

• do not apply to irritated skin or if excessive irritation develops

• do not bandage tightly or use with heating pad or device

Stop use and ask a doctor if:

• you experience pain, swelling or blistering of the skin

• condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days

• arthritic pain persists for more than 10 days, or redness is present

If pregnant or breastfeeding,ask a health professional before use.

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

Ask Doctor (Ask doctor)

Stop use and ask a doctor if:

• you experience pain, swelling or blistering of the skin

• condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days

• arthritic pain persists for more than 10 days, or redness is present

If pregnant or breastfeeding,ask a health professional before use.

Directions

• adults and children 12 years of age and older: Clean and dry affected area, pop apart and partially peel back protective film and apply exposed gel-patch to site of pain. Carefully remove remaining film while pressing the gel-patch to skin and leave in place for up to 8 hours. Use on affected areas not more than 3 to 4 times daily.

• children under 12 years of age: consult a physician

• wash hands after use with cool water

Do Not Use (Do not use)

• do not apply to wounds or damaged skin

• do not apply to irritated skin or if excessive irritation develops

• do not bandage tightly or use with heating pad or device

When Using (When using)

When using this prudocts:

• use only as directed

• avoid contact with eyes or on mucous membranes

• do not apply to wounds or damaged skin

• do not apply to irritated skin or if excessive irritation develops

• do not bandage tightly or use with heating pad or device

Active Ingredient (Active ingredient)

Menthol 5% w/w ...... Purpose: Topical analgesic

Other Information (Other information)

• store at 20-25℃ (68-77℉)

• store in a cool dry place away from direct sunlight

Inactive Ingredients (Inactive ingredients)

Water, Glycerin, Polyacrylic Acid, Propylene Glycol, Sodium Polyacrylate, Mineral Oil, Lavender Essential Oil, Polysorbate 80, PVP, Petrolatum, Dihydroxyaluminum Aminoacetate, Edetate Disodium, Kaolin, Carboxymethylcellulose Sodium, Titanium Dioxide, L-Tartaric Acid, Benzalkonium Chloride, Lauralkonium Chloride

Questions Or Comments (Questions or comments)

Questions or comments : 86-21-31166566

Dosage Forms & Strengths (Dosage forms & strengths)

This is patch dosage form.

The active ingredient strength is 5%.

Pregnancy Or Breast Feeding (Pregnancy or breast feeding)

If pregnant or breastfeeding,ask a health professional before use.

Keep Out of Reach of Children (Keep out of reach of children)

If accidentally ingested, get medical help or contact a Poison Control Center immediately

Package Label. Principal Display Panel (Package label. Principal display panel)


Advanced Ingredient Data


Raw Label Data

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