Label: ACHING HEAD RUB- camphor, menthol ointment
- NDC Code(s): 70722-203-05
- 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)
- Drug Facts
- Active Ingredients
- Purpose
- Uses
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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
- If pregnant or breast feeding
- Keep out of reach of children.
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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
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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
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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 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 LLC (840835115) Establishment Name Address ID/FEI Business Operations Little Moon Essentials LLC 840835115 manufacture(70722-203)
