ECOLYPTUS PAIN RELIEVING MUSCLE RUB- menthol cream

ecolyptus pain relieving muscle rub by

Drug Labeling and Warnings

ecolyptus pain relieving muscle rub by is a Otc medication manufactured, distributed, or labeled by Pure Source, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ecolyptus pain relieving muscle rub

Active Ingredients

Menthol 6.0%

Purpose

External Analgesic

Uses

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

• arthritis
• backache
• strains
• sprains
  

Warnings

For external use only.

Do Not:

• Get into eyes or mucous membranes
• Apply to wounds or damaged skin
• Bandage
  

Stop use and consult a physician if:

Condition worsens, or if symptoms persist for more than 7 days, or clear up and recur.

Keep out of reach of children.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions:

For adults and children 2 years and older: Apply to affected area up to 4 times daily. For children under 2 years of age: Consult a physician.

Inactive Ingredients:

Aqua [Deionized Water], Caprylic/Capric Triglyceride, Cetearyl Olivate, Citric Acid, Eucalyptus Globulus Oil, Gluconolactone, Glycerin, Potassium Sorbate, SD-Alcohol 38B, Sodium Benzoate, Sorbitan Olivate, Xanthan Gum

ecolyptus pain relieving muscle rub 88.7ml (

65121-715-88)

INGREDIENTS AND APPEARANCE

ECOLYPTUS PAIN RELIEVING MUSCLE RUB 
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65121-715
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	60 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EUCALYPTUS OIL (UNII: 2R04ONI662)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
GLYCERIN (UNII: PDC6A3C0OX)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITAN OLIVATE (UNII: MDL271E3GR)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65121-715-88	1 in 1 CARTON	02/09/2017
1		88.7 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/06/2014

Labeler - Pure Source, LLC (080354456)

Establishment
Name	Address	ID/FEI	Business Operations
Pure Source, LLC		080354456	manufacture(65121-715) , repack(65121-715)