MENTHOL- cellulitica 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.

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active ingredient

menthol(1%) analgesic, External
Uses

Uses

Helps relieve the condition of cellulitis infection.

Dosage Suggestion

Adults 10ml maximum per day, Children 5ml maximum per day

Directions

Apply on skin and gentle massage around infected area.

Inactive Ingredient

Thyme Oil, Peppermint Oil, Lemon Oil, Lavender Oil, Geranium Oil (Algerian Type), Olive Oil, Almond Oil, Sunflower Oil, Evening Primrose Oil, Calendula Officinalis Seed Oil.

Warning

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

Warning

Keep out reach of children.

Other Information

Protect this product from excessive heat and direct sun.

package label

fact

all

MENTHOL
cellulitica oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70470-1011
Route of Administration	TOPICAL	DEA Schedule	CV

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.5 mg in 50 mL

Ingredient Name	Strength
Inactive Ingredients
CALENDULA OFFICINALIS SEED OIL (UNII: 9JS8DS42SV)	4.5 mL in 50 mL
ALMOND OIL (UNII: 66YXD4DKO9)	12 mL in 50 mL
PHENOL (UNII: 339NCG44TV)	3 mg in 50 mL
OLIVE OIL (UNII: 6UYK2W1W1E)	21 mL in 50 mL
LEMON OIL (UNII: I9GRO824LL)	1 mL in 50 mL
GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG)	1 mL in 50 mL
LAVENDER OIL (UNII: ZBP1YXW0H8)	1 mL in 50 mL
EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)	6 mL in 50 mL

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70470-1011-5	50 mL in 1 BOTTLE, DROPPER; Type 6: Drug/Biologic Combination	02/29/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	02/29/2016

Labeler - PHYTOPIA CO., LTD. (656940504)

Registrant - PHYTOPIA CO., LTD. (656940504)

Name	Address	ID/FEI	Business Operations
Establishment
PHYTOPIA CO., LTD.		656940504	manufacture(70470-1011) , label(70470-1011)