VITAL VAPOR- camphor, menthol ointment

Vital Vapor by

Drug Labeling and Warnings

Vital Vapor by is a Otc medication manufactured, distributed, or labeled by Little Moon Essentials, Little Moon Essentials LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Camphor 0.6%

Menthol 5.2%

Purpose

Topical Analgesic

Uses

Temporarily relieves minor pain associated with

• simple backache
• muscle strains
• sprains
• bruises

Warning

For exteral use only

When using this product

• ​use only as directed. Read and follow all directions and warnings on this label
• rare cases of serious burns have been reported with products of this type
• do not bandage tightly or apply local heat (such as heating pads) or medicated patches to teh area of use
• avoid contact with eyes and mucous membranes
• do not apply to wounds or damaged, broken or irritated skin
• a trasient burning sensation may occur upon application but generally disappears in several days

Stop use and ask a doctor

• ​condition worsens
• redness is present
• irritation develops
• symptoms persist for more than 7 days or clear up and occur again within a few days
• you experience signs of skin injury such as pain, swelling, or blistering where the product was applied

If pregnant or breast feeding

Ask a health professional before use

Keep out of reach of children

if swallowed, get medical help or contact a Poison Control Center right away

Directions

Adults and children over 12 years:

• Apply a thin layer to affected area
• Massage into painful area until thoroughly absorbed into skin
• Repeat as necessary, but no more than 3 to 4 times daily, allowing a minimum of 2-3 hours between applications
• AFTER APPLYING, WASH HANDS WITH SOAP AND WATER

​​Children 12 years or younger: ask a doctor

Other information

Store at 68-77ºF (20-25ºC)

Protect from excessive moisture

Inactive Ingredients

Organic sesame oil (sesamum indicum)

organic olive oil (olea europaea)

organic ginger powder (zingiber officinale)

organic castor oil (ricinus communis)

beeswax (cera alba)

eucaliptus staigeriana

tea tree oil (melaleuca alternifolia)

wintergreen oil (gaultheria procumbens)

eucalyptus globulus oil

lemongrass oil (cymbopogon citratus)

lavender oil (lavandula angustifolia)

nutmeg oil (myristica fragrans)

ravensara oil (ravensara aromatic)

sage oil (salvia officinalis)

Principle Display Panel 14g container

INGREDIENTS AND APPEARANCE

VITAL VAPOR 
camphor, menthol ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70722-229
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	5.2 g  in 100 g
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	0.6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WEST INDIAN LEMONGRASS OIL (UNII: 5BIA40E9ED)
NUTMEG OIL (UNII: Z1CLM48948)
SAGE OIL (UNII: U27K0H1H2O)
TEA TREE OIL (UNII: VIF565UC2G)
METHYL SALICYLATE (UNII: LAV5U5022Y)
EUCALYPTUS OIL (UNII: 2R04ONI662)
LAVENDER OIL (UNII: ZBP1YXW0H8)
CRYPTOCARYA AGATHOPHYLLA LEAF OIL (UNII: XM00Z00H98)
OLIVE OIL (UNII: 6UYK2W1W1E)
GINGER (UNII: C5529G5JPQ)
CASTOR OIL (UNII: D5340Y2I9G)
YELLOW WAX (UNII: 2ZA36H0S2V)
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)
SESAME OIL (UNII: QX10HYY4QV)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70722-229-05	14 g in 1 CONTAINER; Type 0: Not a Combination Product	10/02/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	10/02/2016

Labeler - Little Moon Essentials (840835115)

Registrant - Little Moon Essentials (840835115)

Establishment
Name	Address	ID/FEI	Business Operations
Little Moon Essentials		840835115	manufacture(70722-229)