Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 8d3d60bc-7ff2-42ec-bc15-f4770ca9e4e4
Route
TOPICAL
Published
Effective Date 2015-08-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oatmeal (0.0003 g)
Inactive Ingredients
Castor Oil Yellow Wax Olive Oil Sunflower Oil Avocado Oil Tocopherol Orange Oil Peppermint Oil Propolis Wax

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2015-08-04

Description

Colloidal Oatmeal (0.1%)

Purpose

Skin Protectant


Medication Information

Purpose

Skin Protectant



Description

Colloidal Oatmeal (0.1%)

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

Directions

Apply generously as needed.



Do Not Use On

cuts, scrapes, or broken skins



Active Ingredient

Colloidal Oatmeal (0.1%)



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)





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.




Structured Label Content

Uses
  • Temporarily relieves pain and itching commonly associated with dryness
  • Helps prevent and heal dry; chapped and cracked lips

Purpose

Skin Protectant



Warnings
  • If irritation or rash persists, consult a physician

Directions

Apply generously as needed.



Do Not Use On (Do not use on)

cuts, scrapes, or broken skins



Active Ingredient (Active ingredient)

Colloidal Oatmeal (0.1%)



Other Information (Other information)

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



Inactive Ingredients (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)





Stop Use and Ask A Doctor (Stop use and ask a doctor)

if irritation or rash persists.



Keep Out of Reach of Children. (Keep out of reach of children.)

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




Advanced Ingredient Data


Raw Label Data

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