SPL v1
SPL
SPL Set ID 4a2aff23-e5a6-668f-e054-00144ff88e88
Route
TOPICAL
Published
Effective Date 2017-03-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (11 g) Camphor (synthetic)
Inactive Ingredients
Petrolatum Paraffin Cajuput Oil Clove Oil

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-03-20

Description

Active ingredients Purpose Camphor 11%........................................................ Topical analgesic Menthol 11%.......................................................... Topical analgesic


Medication Information

Warnings and Precautions

Warnings

For external use only.

Indications and Usage

Directions

  • Rub well on the affected area. Repeat 3 to 4 times dailys.
  • For children 2-12 years, consult a doctor before use.
Dosage and Administration

Distributed by:

MCURE HEALTH SOLUTIONS INC.

20819 Currier Rd #200

City of Industry, CA 91789

Made in China

Description

Active ingredients Purpose Camphor 11%........................................................ Topical analgesic Menthol 11%.......................................................... Topical analgesic

Section 42228-7

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

Section 44425-7

Other information

This product may cause allergic reaction in some individuals. Test on small area before use.

Section 50565-1

Keep out of reach of children.

If swallowed get medical help or contact a Poison Control Center immediately.

Section 50566-9

Stop use and ask a doctor if

  • Condition worsens
  • Severe skin irritation occurs
  • Pain persists for more than seven days
  • Pain clears up and then recurs a few days later
Section 50567-7

When using this product

  • Avoid contact with the eyes and mucous membranes
  • Do not apply to open wounds or damaged skin
  • Do not bandage or use heating pad
Section 51727-6

Inactive ingredients

cajuput oil, clove oil, dementholized mint oil, paraffin petrolatuma

Section 51945-4

Section 55105-1

Uses

For temporary relief of minor aches and pains of muscles and joints associated with over-exertion, simple backache, arhtritis, strains, and sprains.

Section 55106-9

Active ingredients Purpose

Camphor 11%........................................................ Topical analgesic

Menthol 11%.......................................................... Topical analgesic


Structured Label Content

Indications and Usage (34067-9)

Directions

  • Rub well on the affected area. Repeat 3 to 4 times dailys.
  • For children 2-12 years, consult a doctor before use.
Dosage and Administration (34068-7)

Distributed by:

MCURE HEALTH SOLUTIONS INC.

20819 Currier Rd #200

City of Industry, CA 91789

Made in China

Warnings and Precautions (34071-1)

Warnings

For external use only.

Section 42228-7 (42228-7)

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

Section 44425-7 (44425-7)

Other information

This product may cause allergic reaction in some individuals. Test on small area before use.

Section 50565-1 (50565-1)

Keep out of reach of children.

If swallowed get medical help or contact a Poison Control Center immediately.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • Condition worsens
  • Severe skin irritation occurs
  • Pain persists for more than seven days
  • Pain clears up and then recurs a few days later
Section 50567-7 (50567-7)

When using this product

  • Avoid contact with the eyes and mucous membranes
  • Do not apply to open wounds or damaged skin
  • Do not bandage or use heating pad
Section 51727-6 (51727-6)

Inactive ingredients

cajuput oil, clove oil, dementholized mint oil, paraffin petrolatuma

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Uses

For temporary relief of minor aches and pains of muscles and joints associated with over-exertion, simple backache, arhtritis, strains, and sprains.

Section 55106-9 (55106-9)

Active ingredients Purpose

Camphor 11%........................................................ Topical analgesic

Menthol 11%.......................................................... Topical analgesic


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)