PAINAWAY WITH NATURAL PEPPERMINT AND BALSAM PERU- painaway oil

PainAway by

Drug Labeling and Warnings

PainAway by is a Otc medication manufactured, distributed, or labeled by PHYTOPIA CO., LTD., BEAUTY-FACTOR BIOCHEMICAL TECHNOLOGY CO., LTD.,  BEAUTY-FACTOR BIOCHEMICAL TECHNOLOGY CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Drug Facts

menthol(2.6%)

Balsam Peru Oil (2.4%)

Analgesic in the treatment of muscle pain

PURPOSE

Use

Helps relieve the condition of pain and stiffness.

DOSAGE & ADMINISTRATION

Dosage Suggestion

Adults 5ml maximum per day

Children 1ml maximum per day

INDICATIONS & USAGE

Directions

Apply on skin and gentle massage around painful area.

INACTIVE INGREDIENT

Inactive Ingredients

EUCALYPTUS RADIATA LEAF OIL, JAVA CITRONELLA OIL, SUNFLOWER OIL, JOJOBA OIL, ROSEMARY OIL, EVENING PRIMROSE OIL, LEMON OIL, LAVENDER OIL

KEEP OUT OF REACH OF CHILDREN

Warnings

For external use only. Stop use and ask doctor if rash occurs. Keep out reach of children.

STORAGE AND HANDLING

Other Information

Protect this product from excessive heat

and direct sun.

WARNINGS

Warnings

For external use only. Stop use and ask doctor if rash occurs. Keep out reach of children.

PainAway-With natural Peppermint and Balsam Peru Oil

INGREDIENTS AND APPEARANCE

PAINAWAY  WITH NATURAL PEPPERMINT AND BALSAM PERU
painaway oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70470-1118
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1.3 mg  in 50 mg
BALSAM PERU OIL (UNII: DIK0395679) (BALSAM PERU OIL - UNII:DIK0395679)	BALSAM PERU OIL	1.2 mg  in 50 mg

Inactive Ingredients
Ingredient Name	Strength
LEMON OIL (UNII: I9GRO824LL)
EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)
LAVENDER OIL (UNII: ZBP1YXW0H8)
JAVA CITRONELLA OIL (UNII: DBD92X468R)
SUNFLOWER OIL (UNII: 3W1JG795YI)
JOJOBA OIL (UNII: 724GKU717M)
ROSEMARY OIL (UNII: 8LGU7VM393)
EUCALYPTUS RADIATA LEAF OIL (UNII: SB9A7612BD)
GAULTHERIA PROCUMBENS LEAF (UNII: 2125M16OWN)

Product Characteristics
Color	purple (Violet Miron Bottle)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70470-1118-5	50 mg in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	04/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part347	04/01/2016

Labeler - PHYTOPIA CO., LTD. (656940504)

Registrant - BEAUTY-FACTOR BIOCHEMICAL TECHNOLOGY CO., LTD. (656368622)

Establishment
Name	Address	ID/FEI	Business Operations
BEAUTY-FACTOR BIOCHEMICAL TECHNOLOGY CO., LTD.		656368622	manufacture(70470-1118) , label(70470-1118) , pack(70470-1118)