AT ONE WITH NATURE- menthol 1% gel, dentifrice

At One With Nature by

Drug Labeling and Warnings

At One With Nature by is a Otc medication manufactured, distributed, or labeled by BIOCARE LABS INC., RNA PHARMA, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Menthol 1.00%

PURPOSE

Topical Analgesic

USE

temporary relief of itching associated with scalp irritation.

WARNINGS

• for external use only

When using this product

• avoid contact with eyes. If contact occurs rinse eyes thoroughly with water.

Stop use and ask a doctor if

• condition worsens, or if symptoms persist for more than 7 days
• symptoms clear up and occur again within a few days.

• excessive skin irritation

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

• Adult & children 2 year of age & older. Part hair into section & apply a dime size amount sparingly.
• Massage into scalp to invigorate and insure absorption.
• Apply to affected area not more then 3 to 4 times daily. Use daily for maximum results or flaking & itching has stopped.
• Children under 2 years of age ask a doctor

INACTIVE INGREDIENTS

Petrolatum, Helianthus Annuus (Sunflower) Seed Oil, Ricinus Communis (Castor) Seed Oil, Salicylic Acid, Polyethylene, Paraffin, Propylene Glycol, Water, Calendula Officinalis (Pot Marigold ) Flower Extract, Anthemis Nobilis Chamomile Flower Extract , Tilia Cordata (Linden)Flower Extract, Centaurea Cyanus (Cornflower) Flower Extract, Chamomilla Recutita (Matricaria) Flower Extract, Hypericum Perforatum Extract (St. John's Wort) Extract, Fragrance, Olea Europaea (Olive) Fruit Oil, Sulfur, Sesame (Sesamum Indicum) Oil, Tocopheryl Acetate, BHT, Propylparaben, Green 6, Yellow 11

PRINCIPAL DISPLAY PANEL

biocare5oz

INGREDIENTS AND APPEARANCE

AT ONE WITH NATURE 
menthol 1% gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54602-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A)	Menthol	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)
SUNFLOWER OIL (UNII: 3W1JG795YI)
CASTOR OIL (UNII: D5340Y2I9G)
SALICYLIC ACID (UNII: O414PZ4LPZ)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
PARAFFIN (UNII: I9O0E3H2ZE)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)
TILIA CORDATA FLOWER (UNII: CFN6G1F6YK)
CENTAUREA CYANUS FLOWER (UNII: QZ239038YC)
CHAMOMILE (UNII: FGL3685T2X)
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB)
OLIVE OIL (UNII: 6UYK2W1W1E)
SULFUR (UNII: 70FD1KFU70)
SESAME OIL (UNII: QX10HYY4QV)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
D&C GREEN NO. 6 (UNII: 4QP5U84YF7)
D&C YELLOW NO. 11 (UNII: 44F3HYL954)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54602-011-05	154 g in 1 CANISTER	09/18/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	09/18/2014

Labeler - BIOCARE LABS INC. (798953493)

Establishment
Name	Address	ID/FEI	Business Operations
RNA PHARMA, LLC		079103999	manufacture(54602-011)