SPL v5
SPL
SPL Set ID 8e60a0ef-8947-7fa7-e053-2995a90a065c
Route
TOPICAL
Published
Effective Date 2017-07-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (4 g)
Inactive Ingredients
Carbomer Homopolymer, Unspecified Type Trolamine Melaleuca Alternifolia Leaf Aloe Vera Leaf Phenoxyethanol Alpha-tocopherol Acetate Cannabis Sativa Seed Oil Water Arnica Montana Isopropyl Alcohol Camphor (natural) Ilex Paraguariensis Leaf Ethylhexylglycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2019-09-03

Description

Menthol 2%

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

Menthol 2%

Use

Temporary relief from minor aches and pains of sore muscles & joints associated with

  • arthritis
  • simple backache
  • strains
  • bruises
  • sprains.
Section 50565-1

Keep out of reach of children. If accidentally ingested, get medical help or contact a Poison Control Center immediately.

Section 50566-9

Stop use and ask a doctor if conditions worsen, or if symptoms persist for more than 7 days, or clear up and reoccur.

Section 50567-7

When using this product

  • Avoid contact with the eye or mucous membranes
  • Do not apply to wounds or damaged skin
  • Do not use with other ointments, creams, sprays or liniments
  • Do not apply to irritated skin or if excessive irritation develops
  • Do not bandage
  • Wash hands after use with cool water
  • Do not use with heating pad or device
  • Contains sulfur compounds.
Section 53414-9

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

Warnings

For external use only.

Directions

Adults and children 12 years of age and older: Spray onto affected areas no more than 4 times daily; massage not necessary. Children under 12 years of age: consult a physician.

Active Ingredient

Menthol 2%

Other Information

Store in a cool dry place with lid closed tightly.

Inactive Ingredients

dimethyl sulfone, dimethyl sulfoxide, eucalyptus oil*, hydrogen peroxide, peppermint oil*, spike lavender oil*, water.

Relleve Naturals Menthol Spray [​7140288801]

New

7140288801

Relleve Naturals

Deep Penetrating Pain Relief

  • All-Natural Formula
  • Essential Oil Blend
  • For Muscle & Joint Pain

Topical Spray

1 fl oz / 30 ml


Structured Label Content

Use

Temporary relief from minor aches and pains of sore muscles & joints associated with

  • arthritis
  • simple backache
  • strains
  • bruises
  • sprains.
Section 50565-1 (50565-1)

Keep out of reach of children. If accidentally ingested, get medical help or contact a Poison Control Center immediately.

Section 50566-9 (50566-9)

Stop use and ask a doctor if conditions worsen, or if symptoms persist for more than 7 days, or clear up and reoccur.

Section 50567-7 (50567-7)

When using this product

  • Avoid contact with the eye or mucous membranes
  • Do not apply to wounds or damaged skin
  • Do not use with other ointments, creams, sprays or liniments
  • Do not apply to irritated skin or if excessive irritation develops
  • Do not bandage
  • Wash hands after use with cool water
  • Do not use with heating pad or device
  • Contains sulfur compounds.
Section 53414-9 (53414-9)

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

Purpose

Topical analgesic

Warnings

For external use only.

Directions

Adults and children 12 years of age and older: Spray onto affected areas no more than 4 times daily; massage not necessary. Children under 12 years of age: consult a physician.

Active Ingredient

Menthol 2%

Other Information

Store in a cool dry place with lid closed tightly.

Inactive Ingredients

dimethyl sulfone, dimethyl sulfoxide, eucalyptus oil*, hydrogen peroxide, peppermint oil*, spike lavender oil*, water.

Relleve Naturals Menthol Spray [​7140288801] (Relleve Naturals - Menthol Spray [​7140288801])

New

7140288801

Relleve Naturals

Deep Penetrating Pain Relief

  • All-Natural Formula
  • Essential Oil Blend
  • For Muscle & Joint Pain

Topical Spray

1 fl oz / 30 ml


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)