WOMENS RELIEF BALM- camphor, eucalyptus oil, menthol, methyl salicylate cream

Womens Relief Balm by

Drug Labeling and Warnings

Womens Relief Balm by is a Otc medication manufactured, distributed, or labeled by Dr.Sankunni's Ayurvedic Research Foundation Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients   Purpose

Camphor 11%                                           Topical Analgesic

Eucalyptus Oil 10%                                    Anti-Inflammatory

Menthol 8%                                               Topical Analgesic

Wintergreen Oil (Methyl Salicylate) 10%     Topical Analgesic

PURPOSE

Uses: Temporarily relieves minor aches & pains related to

• arthritis
• menstrual cramps
• backaches
• headaches
• bursitis
• sore muscles
• joint pain
• leg cramps
• bruises
• sprains
• strains

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

all natural relief balm coconut 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

coconut oil, paraffin wax, white petroleum jelly, light liquid paraffin, beeswax, clove oil, nutmeg oil, cassia oil, cinnamon oil, peppermint oil, borneol, citronella oil, Jasmine oil

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

WOMENS RELIEF BALM 
camphor, eucalyptus oil, menthol, methyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70146-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
COCONUT OIL (UNII: Q9L0O73W7L)
PARAFFIN (UNII: I9O0E3H2ZE)
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)
PEPPERMINT OIL (UNII: AV092KU4JH)
BORNEOL (UNII: M89NIB437X)
CITRONELLA OIL (UNII: QYO8Q067D0)
CINNAMON OIL (UNII: E5GY4I6YCZ)
HEMP (UNII: TD1MUT01Q7)
PADANG CASSIA OIL (UNII: 0E15252LIW)
JASMINE LACTONE (UNII: H8558L43SR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70146-010-00	20 g in 1 JAR; Type 0: Not a Combination Product	10/25/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	10/25/2016

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

Establishment
Name	Address	ID/FEI	Business Operations
Dr.Sankunni's Ayurvedic Research Foundation Private Limited		650517704	manufacture(70146-010)