SPL v1
SPL
SPL Set ID 42eef404-1d3a-5991-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2016-12-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (0.16 g)
Inactive Ingredients
Glycerin Trolamine Isopropyl Myristate Propylene Glycol Water Capsaicin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-12-05

Description

Menthol 16%


Medication Information

Warnings and Precautions

For external use only

When using this product

  • use only as directed
  • do not bandage tightly or use with a heating pad
  • avoid contact with eyes and mucous membranes
  • do not apply to wounds or damaged, broken or irritated skin
  • a transient burning sensation may occur upon application but generally disappears in several days
  • if severe burning sensation occurs, discontinue use immediately
  • do not expose the area treated with product to heat or direct sunlight

Flammable

  • keep away from fire or flame
Indications and Usage

temporariy relieves minor pain associated with:

  • arthritis
  • simple backache
  • muscle strains
  • sprains
  • bruises
  • cramps
Dosage and Administration

Adults and children over 12 years

  • apply generously to affected area
  • massage into painful area until thoroughly absorbed int skin
  • repeat as necessary, but no more than 3-4 times daily.
Description

Personal Care Solutions

Maximum Strength

Pain Relief Liquid

with no mess roll-on applicator

Long lasting pain relief

  • Powerful, fast acting formula
  • Deep Penetrating Quick Drying
  • Roller Ball Keeps Hands Clean

2.5 fl. oz. (73 ml)

Section 50565-1

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

Section 50566-9

stop use and ask a doctor if

  • condition worsens
  • redness is present
  • irritation develops
  • symptoms persist for more than 7 days or clear up and occur again witin a few days sy
Section 51727-6

acrylates/C10-30 alkyl acrylate crosspolymer, capsaicin, glycerin, isopropyl myristate, propylene glycol, SD alcohol 40 (3

0%), water (245-256)

Section 51945-4

Section 53414-9

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

Section 55105-1

Topical analgesic

Section 55106-9

Menthol 16%

Section 59845-8

Adults and children over 12 years;

  • apply generously to affected area
  • massage into painful area until thoroughly absorbed into skin
  • repeat as necessary, but no more than 3-4 times daily
  • IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER

children 12 years or younger: ask a doctor


Structured Label Content

Indications and Usage (34067-9)

temporariy relieves minor pain associated with:

  • arthritis
  • simple backache
  • muscle strains
  • sprains
  • bruises
  • cramps
Dosage and Administration (34068-7)

Adults and children over 12 years

  • apply generously to affected area
  • massage into painful area until thoroughly absorbed int skin
  • repeat as necessary, but no more than 3-4 times daily.
Warnings and Precautions (34071-1)

For external use only

When using this product

  • use only as directed
  • do not bandage tightly or use with a heating pad
  • avoid contact with eyes and mucous membranes
  • do not apply to wounds or damaged, broken or irritated skin
  • a transient burning sensation may occur upon application but generally disappears in several days
  • if severe burning sensation occurs, discontinue use immediately
  • do not expose the area treated with product to heat or direct sunlight

Flammable

  • keep away from fire or flame
Description (34089-3)

Personal Care Solutions

Maximum Strength

Pain Relief Liquid

with no mess roll-on applicator

Long lasting pain relief

  • Powerful, fast acting formula
  • Deep Penetrating Quick Drying
  • Roller Ball Keeps Hands Clean

2.5 fl. oz. (73 ml)

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

stop use and ask a doctor if

  • condition worsens
  • redness is present
  • irritation develops
  • symptoms persist for more than 7 days or clear up and occur again witin a few days sy
Section 51727-6 (51727-6)

acrylates/C10-30 alkyl acrylate crosspolymer, capsaicin, glycerin, isopropyl myristate, propylene glycol, SD alcohol 40 (3

0%), water (245-256)

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)

Topical analgesic

Section 55106-9 (55106-9)

Menthol 16%

Section 59845-8 (59845-8)

Adults and children over 12 years;

  • apply generously to affected area
  • massage into painful area until thoroughly absorbed into skin
  • repeat as necessary, but no more than 3-4 times daily
  • IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER

children 12 years or younger: ask a doctor


Advanced Ingredient Data


Raw Label Data

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