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NDC 70722-0203-01 Aching Head Rub 3.09; 2.55 g/100g; g/100g Details

Aching Head Rub 3.09; 2.55 g/100g; g/100g

Aching Head Rub is a TOPICAL OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by Little Moon Essentials. The primary component is CAMPHOR (NATURAL); MENTHOL, UNSPECIFIED FORM.

Product Information

NDC	70722-0203
Product ID	70722-203_b7b57849-46b6-e7a4-e053-2a95a90ab190
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Aching Head Rub
Proprietary Name Suffix	n/a
Non-Proprietary Name	Camphor, menthol
Product Type	HUMAN OTC DRUG
Dosage Form	OINTMENT
Route	TOPICAL
Active Ingredient Strength	3.09; 2.55
Active Ingredient Units	g/100g; g/100g
Substance Name	CAMPHOR (NATURAL); MENTHOL, UNSPECIFIED FORM
Labeler Name	Little Moon Essentials
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2024-12-31

Package

Package Images

NDC 70722-0203-01 (70722020301)

Pricing Information	N/A
NDC Package Code	70722-203-01
Billing NDC	70722020301
Package	28 g in 1 CONTAINER (70722-203-01)
Marketing Start Date	2016-09-28
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 3d583d28-f92e-5ca6-e054-00144ff88e88 Details

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

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

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

Labeler - Little Moon Essentials (840835115)

Registrant - Little Moon Essentials LLC (840835115)

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

Revised: 12/2020

Document Id: b7b57849-46b6-e7a4-e053-2a95a90ab190

Set id: 3d583d28-f92e-5ca6-e054-00144ff88e88

Version: 5

Effective Time: 20201230