Womens Relief Balm (Camphor, Eucalyptus Oil, Menthol) Cream [Dr.sankunni's Ayurvedic Research Foundation Private Limited] -

WOMENS RELIEF BALM (CAMPHOR, EUCALYPTUS OIL, MENTHOL) CREAM [DR.SANKUNNI'S AYURVEDIC RESEARCH FOUNDATION PRIVATE LIMITED]
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NDC	70146-006-01, 70146-006-02
Set ID	3826f6e4-044e-062f-e054-00144ff8d46c
Category	HUMAN OTC DRUG LABEL
Packager	Dr.Sankunni's Ayurvedic Research Foundation Private Limited
Generic Name
Product Class
Product Number
Application Number	PART348

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PURPOSE
Uses: Temporarily relieves minor aches & pains related to
- arthritis
- backaches
- bursitis
- sore muscles
- joint pain
- leg cramps
- bruises
- sprains
KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children to avoid accidental ingestion.

If swallowed, get medical help or contact a poison control center immediately.
INDICATIONS & USAGE

ZEN

for aches & pains

women's relief balm jasmine oil

ideal for:

aches & pains related to

rheumatoid arthritis

joint pain

backaches

bursitis

sore muscles

arthritis

leg cramps

sprains and strains
DOSAGE & ADMINISTRATION
Directions:
- use only as directed
- apply generously to affected area 3 to 4 times daily
- children under 12, consult a doctor before use.
WARNINGS
WARNINGS For external use only

When using this product
- discontinue use if excessive irritation of the skin develops
- avoid contact with eyes and mucus membranes
- do not bandage tightly
- do not use with heating pad
Stop use and ask a doctor if
- condition worsens or symptoms persist for more than 7 days
- symptoms clear up and occur again within a few days
- excessive skin irritation occurs
INACTIVE INGREDIENT

Inactive Ingredients

paraffin wax, white petroleum jelly, light liquid paraffin, beeswax, clove oil, nutmeg oil, cassia oil, cinnamon oil, peppermint oil, borneol, citronella oil, jasmine oil
ACTIVE INGREDIENT

Active Ingredients Purpose

Camphor 11% Topical Analgesic

Eucalyptus Oil 10% Anti-Inflammatory

Menthol 8% Topical Analgesic

Topical Analgesic
PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

WOMENS RELIEF BALM
camphor, eucalyptus oil, menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70146-006
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	11 g in 100 g
EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662)	EUCALYPTUS OIL	10 g in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	8 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
PETROLATUM (UNII: 4T6H12BN9U)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
YELLOW WAX (UNII: 2ZA36H0S2V)
CLOVE OIL (UNII: 578389D6D0)
NUTMEG OIL (UNII: Z1CLM48948)
CHINESE CINNAMON OIL (UNII: A4WO0626T5)
CINNAMON OIL (UNII: E5GY4I6YCZ)
PEPPERMINT OIL (UNII: AV092KU4JH)
BORNEOL (UNII: M89NIB437X)
CITRONELLA OIL (UNII: QYO8Q067D0)
JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)
PARAFFIN (UNII: I9O0E3H2ZE)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70146-006-01	5 g in 1 JAR; Type 0: Not a Combination Product	07/21/2016
2	NDC:70146-006-02	20 g in 1 JAR; Type 0: Not a Combination Product	07/21/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	07/21/2016

Labeler - Dr.Sankunni's Ayurvedic Research Foundation Private Limited (650517704)

Name	Address	ID/FEI	Business Operations
Establishment
Dr.Sankunni's Ayurvedic Research Foundation Private Limited		650517704	manufacture(70146-006)

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Medic

WOMENS RELIEF BALM (CAMPHOR, EUCALYPTUS OIL, MENTHOL) CREAM [DR.SANKUNNI'S AYURVEDIC RESEARCH FOUNDATION PRIVATE LIMITED]

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