CERAVINE ORIGINAL MOISTURIZING MULTI-PURPOSE- oatmeal jelly 
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 below 86 F (30 C)


Inactive ingredients

Ricinus Communis (Castor) Seed Oil, Helianthus Annus (Sunflower) Seed Oil, Olea Europaea (Olive) Fruit Oil, Cera Alba (Beeswax), Hydrogenated Vegetable Oil, Tocopherol, Lavandula Angustifolia (Lavender) Oil, Colloidal Oatmeal


Principal Display Panel

Ceravine ORIGINAL

ALL NATURAL INGREDIENTS

Net Wt. 1.7 Fl.oz (50 ml)

MOISTURIZING MULTI-PURPOSE OIL JELLY




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CERAVINE ORIGINAL  MOISTURIZING MULTI-PURPOSE
oatmeal jelly
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61403-020
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL0.0485 g  in 50 g
Inactive Ingredients
Ingredient NameStrength
YELLOW WAX (UNII: 2ZA36H0S2V)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
TOCOPHEROL (UNII: R0ZB2556P8)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
CASTOR OIL (UNII: D5340Y2I9G)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61403-020-0150 g in 1 CARTON; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34707/24/2015
Labeler - Biostandard Inc. (688735402)
Registrant - Biostandard Inc. (688735402)
Establishment
NameAddressID/FEIBusiness Operations
Biostandard Inc.688735402manufacture(61403-020)

Revised: 7/2015
Document Id: 14d150ca-7d4d-4656-a633-d8b8b37726c7
Set id: ad9c6b37-61b3-4703-aa67-8a06d6b39440
Version: 1
Effective Time: 20150724
 
Biostandard Inc.