Assured™ Muscle Rub

Assured™ Muscle Rub
SPL v3
SPL
SPL Set ID 81317756-e678-40fa-95ea-a9d7ecd98481
Route
TOPICAL
Published
Effective Date 2017-12-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol, Unspecified Form (2.5 g)
Inactive Ingredients
Camphor (synthetic) Dmdm Hydantoin Isopropyl Alcohol Polyoxyl 40 Hydrogenated Castor Oil Sodium Hydroxide Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2012-05-15

Description

Drug Facts

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Drug Facts

Use

Temporarily relieves the minor aches and pains in muscles and joints associated with:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

Section 53414-9

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

Warnings

For external use only.

Avoid contact with the eyes or on mucous membranes.

Directions
  • Adults and children 2 years of age and older: apply to affected area up to 3 to 4 times daily.
  • Children under 2 years of age: consult a doctor
Do Not Use
  • on wounds or damaged skin
Stop Use If
  • excessive irritation develops
Active Ingredient

Menthol 2.5%

Other Information
  • store at 15 to 30°C (59 to 86°F)
  • Tamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING.
Inactive Ingredients

Camphor, carbomer, DMDM hydantoin, isoceteth-20, isopropyl alcohol, PEG-40 hydrogenated castor oil, purified water, sodium hydroxide

Questions Or Comments?

866-323-0107 or www.natureplex.com

When Using This Product
  • do not bandage or wrap tightly
Stop Use and Ask A Doctor If
  • condition worsens or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
Principal Display Panel 42.5 G Tube Carton

ASSURED

EXTRA STRENGTH PAIN RELIEVING GEL

Muscle Rub

Menthol 2.5%

Fast relief from:

  • Arthritis pain
  • Backache
  • Muscle pain
  • Joint pain

NET WT 1.5 OZ (42.5 g)


Structured Label Content

Use

Temporarily relieves the minor aches and pains in muscles and joints associated with:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

Section 53414-9 (53414-9)

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

Purpose

Topical Analgesic

Warnings

For external use only.

Avoid contact with the eyes or on mucous membranes.

Directions
  • Adults and children 2 years of age and older: apply to affected area up to 3 to 4 times daily.
  • Children under 2 years of age: consult a doctor
Do Not Use (Do not use)
  • on wounds or damaged skin
Stop Use If (Stop use if)
  • excessive irritation develops
Active Ingredient (Active ingredient)

Menthol 2.5%

Other Information (Other information)
  • store at 15 to 30°C (59 to 86°F)
  • Tamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING.
Inactive Ingredients (Inactive ingredients)

Camphor, carbomer, DMDM hydantoin, isoceteth-20, isopropyl alcohol, PEG-40 hydrogenated castor oil, purified water, sodium hydroxide

Questions Or Comments? (Questions or comments?)

866-323-0107 or www.natureplex.com

When Using This Product (When using this product)
  • do not bandage or wrap tightly
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
Principal Display Panel 42.5 G Tube Carton (PRINCIPAL DISPLAY PANEL - 42.5 g Tube Carton)

ASSURED

EXTRA STRENGTH PAIN RELIEVING GEL

Muscle Rub

Menthol 2.5%

Fast relief from:

  • Arthritis pain
  • Backache
  • Muscle pain
  • Joint pain

NET WT 1.5 OZ (42.5 g)


Advanced Ingredient Data


Raw Label Data

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