CERAVINE LIP BALM- oatmeal stick

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 dryness
• Helps prevent and heal dry; chapped and cracked lips
  

Warnings

• If irritation or rash persists, consult a physician
  

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)

INGREDIENTS AND APPEARANCE

CERAVINE LIP BALM 
oatmeal stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61403-030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	0.0003 g  in 5 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61403-030-01	1 in 1 CARTON
1		5 g in 1 APPLICATOR; 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	08/04/2015

Labeler - Biostandard Inc. (688735402)

Registrant - Biostandard Inc. (688735402)

Establishment
Name	Address	ID/FEI	Business Operations
Biostandard Inc.		688735402	manufacture(61403-030)