FLOWER O LIFE PAIN RELIEVING BALM- camphor, menthol, wintergreen oil oil

Flower O Life by

Drug Labeling and Warnings

Flower O Life by is a Otc medication manufactured, distributed, or labeled by Skin Deep, Yoga Spot Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Camphor (6.0%)

Menthol (15.0%)

Wintergreen Oil (30.0%)

Purpose

Counterirritant

Counterirritant

Counterirritant

Uses

For the temporary relief of minor aches and pains of muscles and joints.

Warnings

For external use only

Avoid contact with the eyes

If condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician

Do not apply to wounds or damaged skin

Do not bandage tightly

If pregnant or breast-feeding

Ask health professional before use

Keep out of reach of children

Keep out of reach of children

In case of accidental ingestion seek professional assistance of contact a Poison Control Center immediately.

Directions

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.

Children under 2 years of age: Consult a physician.

Inactive Ingredients

Mentha Piperita (Peppermint) Leaf Extract, Eucalyptus Globulus Leaf Oil, Lavandula Angustifolia (Lavender) Oil, Geranium Maculatum Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil

Questions or Comments

Please contact us at www.flowerolife.com

Principal Display Panel

Flower O Life

Pain Relieving Balm

1 oz./30 mL

Manufactured by SkinDeep

Savannah, Georgia USA

FlowerOLife Inc

Brooklyn, NY 11223

INGREDIENTS AND APPEARANCE

FLOWER O LIFE  PAIN RELIEVING BALM
camphor, menthol, wintergreen oil oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 45156-2250
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Camphor (Natural) (UNII: N20HL7Q941) (Camphor (Natural) - UNII:N20HL7Q941)	Camphor (Natural)	6 g  in 100 g
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A)	Menthol	15 g  in 100 g
Methyl Salicylate (UNII: LAV5U5022Y) (Methyl Salicylate - UNII:LAV5U5022Y)	Methyl Salicylate	30 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
Peppermint (UNII: V95R5KMY2B)
Corymbia Citriodora Leaf Oil (UNII: M63U6N96EB)
Lavender Oil (UNII: ZBP1YXW0H8)
Geranium Maculatum Root (UNII: 93IXI5B6OJ)
Tea Tree Oil (UNII: VIF565UC2G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 45156-2250-2	1 in 1 BOX
1	NDC: 45156-2250-1	29 g in 1 BOTTLE, GLASS

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part348	08/08/2011

Labeler - Skin Deep (833276566)

Registrant - Yoga Spot Inc (601626703)

Establishment
Name	Address	ID/FEI	Business Operations
Skin Deep		833276566	manufacture