CERAVINE LIP BALM - oatmeal stick 
Biostandard 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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Drug Facts

Active ingredient

Colloidal Oatmeal (0.1%)


Purpose

Skin Protectant


Uses

Warnings

Do not use on

cuts, scrapes, or broken skins


Stop use and ask a doctor

if irritation or rash persists.


Keep out of reach of children.

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


Directions

Apply generously as needed.


Other information

Store between 0 C to 28 C (62 F to 82.4 F)


Inactive ingredients

Ricinus Communis (Castor) Seed Oil, Cera Alba (Beeswax), Olea Europaea (Olive) Fruit Oil, Helianthus Annus (Sunflower) Seed Oil, Persea Gratissima (Avocado) Oil, Hydrogenated Vegetable Oil, Tocopherol, Citrus Sinensis (Orange) Oil, Mentha Piperita (Peppermint) Oil, Propolis Extract, Fibroin


Principal Display Panel

Ceravine LIP BALM

100% Natural Ingredients

Net Wt. 0.17 oz (5g)



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CERAVINE LIP BALM 
oatmeal stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61403-030
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL0.0003 g  in 5 g
Inactive Ingredients
Ingredient NameStrength
CASTOR OIL (UNII: D5340Y2I9G)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
AVOCADO OIL (UNII: 6VNO72PFC1)  
TOCOPHEROL (UNII: R0ZB2556P8)  
ORANGE OIL (UNII: AKN3KSD11B)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61403-030-011 in 1 CARTON
15 g in 1 APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34708/04/2015
Labeler - Biostandard Inc. (688735402)
Registrant - Biostandard Inc. (688735402)
Establishment
NameAddressID/FEIBusiness Operations
Biostandard Inc.688735402manufacture(61403-030)

Revised: 8/2015
Document Id: 564e7052-6226-442f-a229-f7839d93b4e3
Set id: 8d3d60bc-7ff2-42ec-bc15-f4770ca9e4e4
Version: 1
Effective Time: 20150804
 
Biostandard Inc.