pain relief spray

pain relief spray
SPL v2
SPL
SPL Set ID d12a84cb-7211-1ccd-e053-2995a90a3d39
Route
topical
Published
Effective Date 2021-11-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (10 g)
Inactive Ingredients
arnica montana flower alcohol water indian frankincense european elderberry mentha piperita camphor (natural) glycerin

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2021-11-19

Purpose

Menthol 10%...................Topical Analgesic

Description

Menthol 10%


Medication Information

Warnings

For external use only.

Uses

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

  • strains
  • bruises
  • simple backache
  • arthritis
  • sprains
Purpose

Menthol 10%...................Topical Analgesic

Directions
  • Use only as directed
  • Adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
  • Children under 12 years of age: ask a doctor
Inactive Ingredients

SD Alcohol 40-B, Water, Sambucus Nigra Fruit Extract, Boswellia Serrata Extract, Camphor, Mentha Piperita Oil, Glycerin, Arnica Montana Flower Extract

Description

Menthol 10%

Section 50565-1

Keep out of reach of children. 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 or symptoms persist for more than 7 days or clear up and occur again within a few days
Section 50567-7

When using this product

  • avoid contact with eyes or mucous membranes
  • do not bandage tightly
Section 50570-1

Do not use

  • on wounds or damaged, broken, or irritated skin
  • with a heating pad
Section 51945-4

Sagely Naturals

Extra Strength

Pain Relief Spray

95% Natural Ingredients

Instant Cooling

with 10% Menthol

2 Fl Oz / 60 mL

Section 53414-9

If pregnant or breastfeeding, ask a health professional before use.

Active Ingredient

Menthol 10%


Structured Label Content

Warnings

For external use only.

Uses

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

  • strains
  • bruises
  • simple backache
  • arthritis
  • sprains
Purpose

Menthol 10%...................Topical Analgesic

Directions
  • Use only as directed
  • Adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
  • Children under 12 years of age: ask a doctor
Inactive Ingredients (Inactive ingredients)

SD Alcohol 40-B, Water, Sambucus Nigra Fruit Extract, Boswellia Serrata Extract, Camphor, Mentha Piperita Oil, Glycerin, Arnica Montana Flower Extract

Section 50565-1 (50565-1)

Keep out of reach of children. 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 or symptoms persist for more than 7 days or clear up and occur again within a few days
Section 50567-7 (50567-7)

When using this product

  • avoid contact with eyes or mucous membranes
  • do not bandage tightly
Section 50570-1 (50570-1)

Do not use

  • on wounds or damaged, broken, or irritated skin
  • with a heating pad
Section 51945-4 (51945-4)

Sagely Naturals

Extra Strength

Pain Relief Spray

95% Natural Ingredients

Instant Cooling

with 10% Menthol

2 Fl Oz / 60 mL

Section 53414-9 (53414-9)

If pregnant or breastfeeding, ask a health professional before use.

Active Ingredient (Active ingredient)

Menthol 10%


Advanced Ingredient Data


Raw Label Data

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