AT ONE WITH NATURE- menthol 1% gel, dentifrice 
BIOCARE LABS INC.

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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At One with nature Root Revitalizer for Dry Itchy Scalp

ACTIVE INGREDIENT

Menthol 1.00%

PURPOSE

Topical Analgesic

USE

temporary relief of itching associated with scalp irritation.

WARNINGS

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

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

biocare5oz

AT ONE WITH NATURE 
menthol 1% gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54602-011
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54602-011-05154 g in 1 CANISTER09/18/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/18/2014
Labeler - BIOCARE LABS INC. (798953493)
Establishment
NameAddressID/FEIBusiness Operations
RNA PHARMA, LLC079103999manufacture(54602-011)

Revised: 11/2014
Document Id: 0db34654-d5f1-468f-b422-c22ccbef396f
Set id: 206af367-45c3-4448-ab55-71bc9dcf785c
Version: 1
Effective Time: 20141103
 
BIOCARE LABS INC.