Pure-aid Cold & Hot Sleeve

Pure-aid Cold & Hot Sleeve
SPL v2
SPL
SPL Set ID 1a11d455-c8e5-4ee7-8e0b-6c3eefc29c86
Route
TOPICAL
Published
Effective Date 2012-04-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (400 mg)
Inactive Ingredients
Glycerin Isopropyl Alcohol Polysorbate 80 Methylparaben Propylparaben Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2012-04-19
Description

Menthol 16%

Purpose

Topical analgesic

Medication Information

Purpose

Topical analgesic

Description

Menthol 16%

Uses

Temporarily relieves minor pain associated with arthritis, bursitis, tendonitis, muscle strains, muscle sprains, bruises and cramps.

Warnings

For external use only

Directions

Adults and children over 12 years

  • Clean and dry affected area.
  • Cut open pouch and remove Sleeve.
  • Remove the clear plastic insert.
  • Pull Sleeve onto knee, large ankle or elbow.
  • Medication is on the colored section of the Sleeve, so the colored section should be placed on the affected area.
  • Pull Sleeve over itself to make medicine touch directly on your skin.
  • Apply one Sleeve to affected area.
  • Repeat as necessary , but no more than 4 times a day.
  • Sleeve should fit snug, but not tight.

Children 12 years or younger:

  • ask a doctor

Package Label

Active Ingredient

Menthol 16%

Inactive Ingredients

Glycerin, Hydroxyethylcellulose, Isopropyl Alcohol, Polysorbate 80, Methylparaben, Propylparaben, Purified Water

When Using This Product
  • use only as directed
  • do not bandage tightly or use with a heating pad
  • avoid contact with eyes and mucous membrane
  • do not apply to wounds or damaged skin

Stop Use and Ask A Doctor If
  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • redness is present
  • irritation develops

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

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

Structured Label Content

Uses

Temporarily relieves minor pain associated with arthritis, bursitis, tendonitis, muscle strains, muscle sprains, bruises and cramps.

Purpose

Topical analgesic

Warnings

For external use only

Directions

Adults and children over 12 years

  • Clean and dry affected area.
  • Cut open pouch and remove Sleeve.
  • Remove the clear plastic insert.
  • Pull Sleeve onto knee, large ankle or elbow.
  • Medication is on the colored section of the Sleeve, so the colored section should be placed on the affected area.
  • Pull Sleeve over itself to make medicine touch directly on your skin.
  • Apply one Sleeve to affected area.
  • Repeat as necessary , but no more than 4 times a day.
  • Sleeve should fit snug, but not tight.

Children 12 years or younger:

  • ask a doctor

Package Label (Package label)

Active Ingredient (Active ingredient)

Menthol 16%

Inactive Ingredients (Inactive ingredients)

Glycerin, Hydroxyethylcellulose, Isopropyl Alcohol, Polysorbate 80, Methylparaben, Propylparaben, Purified Water

When Using This Product (When using this product)
  • use only as directed
  • do not bandage tightly or use with a heating pad
  • avoid contact with eyes and mucous membrane
  • do not apply to wounds or damaged skin

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • redness is present
  • irritation develops

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:40.868482 · Updated: 2026-03-14T22:58:19.730903