ACHING HEAD RUB- camphor, menthol ointment 
Little Moon Essentials

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active Ingredients

Camphor 3.09%

Menthol 2.55%

Purpose

Topical Analgesic

Uses

temporarily relieves minor pain associated with

Warning

For external 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 no 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, broken or irritated skin.

A transient burning sensation may occur upon application but generally disappears in several days.

Stop use and ask 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, swelling, or blistering where the product was applied

If pregnant or breastfeeding

ask a health professional before use

Directions

Adults and children over 12 years

Children 12 years or younger: ask a doctor

Keep out of reach of children

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

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)

wintergreen oil (gaultheria procumbens)

marjoram (thymus mastichina)

cinnamon oil (cinnamomum zeylanicum)

lavender oil (lavandula angustifolia)

eucalyptus globulus

clary sage (salvia sclarea)

rosemary oil (rosmarinus officinalis)

basil oil (ocimum basillicum)

peppermint oil (menthe piperita)

Principle Display Panel-28g Container

1oz Aching Head Rub Label1oz Aching Head Rub Bottom

ACHING HEAD RUB 
camphor, menthol ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70722-203
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM2.55 g  in 100 g
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)3.09 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
GINGER (UNII: C5529G5JPQ)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
SWEET MARJORAM (UNII: G9Z40ZYU6P)  
CINNAMON OIL (UNII: E5GY4I6YCZ)  
CLARY SAGE OIL (UNII: 87L0D4U3M0)  
ROSEMARY OIL (UNII: 8LGU7VM393)  
BASIL OIL (UNII: Z129UMU8LE)  
SESAME OIL (UNII: QX10HYY4QV)  
CASTOR OIL (UNII: D5340Y2I9G)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70722-203-0128 g in 1 CONTAINER; Type 0: Not a Combination Product09/28/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/26/2016
Labeler - Little Moon Essentials (840835115)
Registrant - Little Moon Essentials LLC (840835115)
Establishment
NameAddressID/FEIBusiness Operations
Little Moon Essentials LLC840835115manufacture(70722-203)

Revised: 12/2020
Document Id: b7b52adc-15dd-1a53-e053-2995a90a72b6
Set id: 3d4159c7-5efe-0d0d-e054-00144ff8d46c
Version: 4
Effective Time: 20201230
 
Little Moon Essentials