Winco Cold & Hot Medicated Patch Large 5ct Zdp (24192a)

Winco Cold & Hot Medicated Patch Large 5ct Zdp (24192a)
SPL v8
SPL
SPL Set ID af0d86c4-f74e-2dbe-e053-2a95a90a74c1
Route
TOPICAL
Published
Effective Date 2020-09-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (50 mg)
Inactive Ingredients
Kaolin Methylparaben Polysorbate 80 Titanium Dioxide Tartaric Acid Sorbitan Monooleate Water Glycerin Alcohol Sodium Polyacrylate (2500000 Mw) Propylparaben Dihydroxyaluminum Aminoacetate Anhydrous

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-09-11

Description

Active ingredient..................................Purpose Methol 5%................................Topical Analgesic


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Directions

-open pouch and remove patch

-carefully peel off protective backing and apply sticky side to affected area

-adults and children 12 years of age and older:

  • do not wear patch for more than 8 hours
  • apply to affected area no more than 3 times daily

-children under 12 years of age: consult a doctor

Dosage and Administration

Distributed By:

WINCO FOODS, LLC,

BOISE, ID 83704

MADE IN CHINA

Description

Active ingredient..................................Purpose Methol 5%................................Topical Analgesic

Section 44425-7

Other Information

  • store at room temperature 20-25ºC (68-77ºF)
Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 50566-9

Stop use and ask a doctor if

  • condition worsens or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
  • excessive skin irritation occurs
Section 50567-7

When using this product

  • use only as directed
  • avoid contact with eyes or mucous membranes
  • do not bandage tightly
  • discontiue use at least 1 hour before a bath or shower
  • do not use immedialtely after a bath or shower
Section 50569-3

Ask a doctor before use if you have

  • redness over the affected area
Section 50570-1
  • on wounds or damaged skin
  • with a heating pad
  • on a child under 12 years of age with arthritis-like conditions
Section 51727-6

Inactive ingredients alcohol, aluminum glycinate, glycerin, kaolin, methylparaben, polysorbate 80, propylparaben, purified water, sodium polyacrylate, sorbitan monooleate, tartaric acid, titanium dioxide

Section 51945-4

Section 53414-9

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

Section 55105-1

Uses

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

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
Section 55106-9

Active ingredient..................................Purpose

Methol 5%................................Topical Analgesic


Structured Label Content

Indications and Usage (34067-9)

Directions

-open pouch and remove patch

-carefully peel off protective backing and apply sticky side to affected area

-adults and children 12 years of age and older:

  • do not wear patch for more than 8 hours
  • apply to affected area no more than 3 times daily

-children under 12 years of age: consult a doctor

Dosage and Administration (34068-7)

Distributed By:

WINCO FOODS, LLC,

BOISE, ID 83704

MADE IN CHINA

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 44425-7 (44425-7)

Other Information

  • store at room temperature 20-25ºC (68-77ºF)
Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • condition worsens or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
  • excessive skin irritation occurs
Section 50567-7 (50567-7)

When using this product

  • use only as directed
  • avoid contact with eyes or mucous membranes
  • do not bandage tightly
  • discontiue use at least 1 hour before a bath or shower
  • do not use immedialtely after a bath or shower
Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • redness over the affected area
Section 50570-1 (50570-1)
  • on wounds or damaged skin
  • with a heating pad
  • on a child under 12 years of age with arthritis-like conditions
Section 51727-6 (51727-6)

Inactive ingredients alcohol, aluminum glycinate, glycerin, kaolin, methylparaben, polysorbate 80, propylparaben, purified water, sodium polyacrylate, sorbitan monooleate, tartaric acid, titanium dioxide

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Uses

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

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
Section 55106-9 (55106-9)

Active ingredient..................................Purpose

Methol 5%................................Topical Analgesic


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)