ACHING HEAD RUB- camphor, menthol ointment

Aching Head Rub by

Drug Labeling and Warnings

Aching Head Rub 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 3.09%

Menthol 2.55%

Purpose

Topical Analgesic

Uses

Temporarily relieves minor pain associated with

• ​simple backache
• muscle strains
• sprains
• bruises

Warning

For external use only

When using this product use only as directed read and follow a directions and warnings on this label

• Rare cases of serius 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 the area of use
• Avoid contact with eyes and mucous membranes
• Do not apply to wounds or damaged skin, broken or irritated skin
• A trasient burning sensation may occur upon application but generaly disappears in several days.

Stop use and ask a doctor if

• 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 , sweling 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 Poison Control Center rigt away.

Directions

Adults and children over 12 years

• Apply a thin layer to affected area
• Massage into painful area until thoroughly absorbed into daily
• 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 officinales)

Orgnic Castor oil (Ricinus Communis)

Beeswax (Cera Alba)

Wintergreen oil (Gaultheria Procumbens)

Marjoram (Thymus Mastichina)

Cinnamon oil (Cinnamomum Zeynalicum)

Lavender oil (Lavandula Angustifolia)

Eucalytus globulus

Clary sage (Salvia Sclarea)

Rosemary oil(Rosmarinus Officinalis)

Basil oil (Ocimum basilicum)

Peppermint oil (Mentha Piperita)

Principle Display Panel- 14g Container

INGREDIENTS AND APPEARANCE

ACHING HEAD RUB 
camphor, menthol ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70722-203
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	2.55 g  in 100 g
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	3.09 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y)
GINGER OIL (UNII: SAS9Z1SVUK)
CASTOR OIL (UNII: D5340Y2I9G)
YELLOW WAX (UNII: 2ZA36H0S2V)
SWEET MARJORAM OIL (UNII: ICH7BE016E)
CINNAMON OIL (UNII: E5GY4I6YCZ)
LAVENDER OIL (UNII: ZBP1YXW0H8)
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)
CLARY SAGE (UNII: U3HSK5JC0Q)
ROSEMARY OIL (UNII: 8LGU7VM393)
BASIL OIL (UNII: Z129UMU8LE)
PEPPERMINT OIL (UNII: AV092KU4JH)
SESAME OIL (UNII: QX10HYY4QV)
OLIVE OIL (UNII: 6UYK2W1W1E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70722-203-05	14 g in 1 CONTAINER; Type 0: Not a Combination Product	09/28/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	09/26/2016

Labeler - Little Moon Essentials (840835115)

Registrant - Little Moon Essentials (840835115)

Establishment
Name	Address	ID/FEI	Business Operations
Little Moon Essentials		840835115	manufacture(70722-203)