MUSCLE MIST- menthol, camphor solution

Muscle Mist by

Drug Labeling and Warnings

Muscle Mist by is a Otc medication manufactured, distributed, or labeled by Signature Formulations LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Menthol USP 6%
Camphor 2%

Purpose

Pain Relief

Other ingredients

The Isopropyl Alcohol, Camphor Powder, Eucalyptus, Globulus Leaf Oil, Sweet Birch Oil, Peppermint Oil, Clove Bud Oil

Uses

For the temporary relief of minor aches and pains at muscles and joints associated with sore muscles, strains, joint discomfort and arthritis

Warnings

For external use only. Avoid contact with eyes. Do not apply to wounds or damaged skin. If pregnant or breast feeding ask a health care professional before use. Keep out of reach of children. If swallowed get medical help or contact a poison control center. Flammable: Keep away from fire or flame.

Keep Out of Reach of Children

Directions

Adults and children over 12 years. Spray onto neck and shoulders to help relieve tension and stress. Rub into temples to help with headaches. Spray onto chest to help relieve cold and flu. Apply prior to a workout or sports activity

Manufactured for:

Holistic Earth Remedies
Phoenix, Arizona 602.300.3691
holisticearthremedies.com

Package/Label Principal Display Panel

HERBAL
MUSCLE MIST

THE NATURAL SOLUTION THAT WORKS!

Help reduce…

Inflammation ●
Arthritis ●
Back Pain ●
Muscle Aches ●
Joint Pain ●
Restores Blood Flow ●

Holistic Earth Remedies

4 FL OZ (120ml)

Carton Label

INGREDIENTS AND APPEARANCE

MUSCLE MIST 
menthol, camphor solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69257-110
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	6 g  in 100 mL
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302)
EUCALYPTUS OIL (UNII: 2R04ONI662)
METHYL SALICYLATE (UNII: LAV5U5022Y)
PEPPERMINT OIL (UNII: AV092KU4JH)
CLOVE OIL (UNII: 578389D6D0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69257-110-10	120 mL in 1 BOTTLE, SPRAY; 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	10/20/2014

Labeler - Signature Formulations LLC (079126258)

Registrant - Signature Formulations LLC (079126258)

Establishment
Name	Address	ID/FEI	Business Operations
Signature Formulations LLC		079126258	MANUFACTURE(69257-110)