Label: ACHING HEAD RUB- camphor, menthol ointment
- NDC Code(s): 70722-203-01
- Packager: Little Moon Essentials
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated December 30, 2020
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
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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
- If pregnant or breastfeeding
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Directions
Adults and children over 12 years
- Apply a thin layer to affected area
- Massage into painful area until throughly absorbed into skin
- Repeat as necessary, but no more than 3 to 4 times daily, allowing a minimum of 2-3 hours bewteen applications.
- AFTER APPLYING, WASH HANDS WITH SOAP AND WATER
Children 12 years or younger: ask a doctor
- Keep out of reach of children
- Other Information
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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
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INGREDIENTS AND APPEARANCE
ACHING HEAD RUB
camphor, menthol ointmentProduct 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 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:70722-203-01 28 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 LLC (840835115) Establishment Name Address ID/FEI Business Operations Little Moon Essentials LLC 840835115 manufacture(70722-203)
