PAINAWAY WITH NATURAL PEPPERMINT AND BALSAM PERU- painaway oil

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A), BALSAM PERU OIL (UNII: DIK0395679) (BALSAM PERU OIL - UNII:DIK0395679)

Available from:

PHYTOPIA CO., LTD.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Use Helps relieve the condition of pain and stiffness. Directions Apply on skin and gentle massage around painful area.

Authorization status:

OTC monograph not final

Summary of Product characteristics

PAINAWAY WITH NATURAL PEPPERMINT AND BALSAM PERU- PAINAWAY OIL
PHYTOPIA CO., LTD.
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may be marketed if they_
_comply with applicable regulations and policies. FDA has not
evaluated whether this product complies._
----------
DRUG FACTS
menthol(2.6%)
Balsam Peru Oil (2.4%)
Analgesic in the treatment of muscle pain
US E
Helps relieve the condition of pain and stiffness.
DOSAGE SUGGESTION
Adults 5ml maximum per day
Children 1ml maximum per day
DIRECTIONS
Apply on skin and gentle massage around painful area.
INACTIVE INGREDIENTS
EUCALYPTUS RADIATA LEAF OIL, JAVA CITRONELLA OIL, SUNFLOWER OIL,
JOJOBA
OIL, ROSEMARY OIL, EVENING PRIMROSE OIL, LEMON OIL, LAVENDER OIL
WARNINGS
For external use only. Stop use and ask doctor if rash occurs. Keep
out reach of children.
OTHER INFORMATION
Protect this product from excessive heat
and direct sun.
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
PAINAWAY WITH NATURAL PEPPERMINT AND BALSAM PERU
painaway oil
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:70 470 -1118
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
MENTHO L (UNII: L7T10 EIP3A) (MENTHOL - UNII:L7T10 EIP3A)
MENTHOL
1.3 mg in 50 mg
BALSAM PERU O IL (UNII: DIK0 39 56 79 ) (BALSAM PERU OIL - UNII:DIK0
39 56 79 )
BALSAM PERU OIL
1.2 mg in 50 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
LEMO N O IL (UNII: I9 GRO8 24LL)
EVENING PRIMRO SE O IL (UNII: 3Q9 L0 8 K71N)
LAVENDER O IL (UNII: ZBP1YXW0 H8 )
JAVA CITRO NELLA O IL (UNII: DBD9 2X46 8 R)
SUNFLO WER O IL (UNII: 3W1JG79 5YI)
JO JO BA O IL (UNII: 724GKU717M)
RO SEMARY O IL (UNII: 8 LGU7VM39 3)
EUCALYPTUS RADIATA LEAF O IL (UNII: SB9 A76 12BD)
GAULTHERIA PRO CUMBENS LEAF (UNII: 2125M16 OWN)
PRODUCT CHARACTERISTICS
COLOR
purple (Vio let Miro n Bo ttle)
S CORE
S HAP E
S IZ E
FLAVOR
IMPRINT CODE
CONTAINS
PAC