Cvs Cold & Hot Medicated Patch Small, 5ct 47516a Zdp

Cvs Cold & Hot Medicated Patch Small, 5ct 47516a Zdp
SPL v7
SPL
SPL Set ID a44cec95-822a-40b6-e053-2995a90ae31c
Route
TOPICAL
Published
Effective Date 2020-10-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (50 mg)
Inactive Ingredients
Glycerin Kaolin Polysorbate 80 Tartaric Acid Propylparaben Sodium Polyacrylate (8000 Mw) Methylparaben Sorbitan Monooleate Titanium Dioxide Alcohol Dihydroxyaluminum Aminoacetate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-10-02

Description

Active ingredient Purpose Menthol 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: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

Made in China

Description

Active ingredient Purpose Menthol 5%.........................................Topical analgesic

Section 44425-7

Other information

  • store at room temperature 20-25°C (68-77°F)
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
  • discontinue use at least 1 hour before a bath or shower
  • do not use immediately after a bath or shower
Section 50569-3

Ask a doctor before use if you have

  • redness over the affected area
Section 50570-1

Do not use

  • 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

Menthol 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: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

Made in China

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 44425-7 (44425-7)

Other information

  • store at room temperature 20-25°C (68-77°F)
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
  • discontinue use at least 1 hour before a bath or shower
  • do not use immediately 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)

Do not use

  • 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

Menthol 5%.........................................Topical analgesic


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)