CERAVINE ORIGINAL MOISTURIZING MULTI-PURPOSE- oatmeal jelly

Drug Labeling and Warnings

Drug Details [pdf]

Active ingredient

Colloidal Oatmeal (0.1%)

Purpose

Skin Protectant

Uses

• Temporarily relieves pain and itching commonly associated with skin dryness
• Helps prevent and temporarily protects chafed, chapped or cracked skin
  

Warnings

• For external use only
  

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

INGREDIENTS AND APPEARANCE

CERAVINE ORIGINAL  MOISTURIZING MULTI-PURPOSE
oatmeal jelly

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61403-020
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	0.0485 g  in 50 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61403-020-01	50 g in 1 CARTON; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	07/24/2015

Labeler - Biostandard Inc. (688735402)

Registrant - Biostandard Inc. (688735402)

Establishment
Name	Address	ID/FEI	Business Operations
Biostandard Inc.		688735402	manufacture(61403-020)