CLARA 1984- dimethicone cream
CLARA GROUP

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.

----------

ACTIVE INGREDIENT

Active Ingredient: DIMETHICONE 1.0%

INACTIVE INGREDIENT

Inactive Ingredients:
Vaseline, Sophora Japanese, Myrobalan, Ginger, Madder, Akanthopanax, Gomphocarpus, Zigadenus, Liquidambar, Aristolochia, Anacamptis, Cinnamon, Saffron powder, Wild rose, Peppermint, violet , Olive

PURPOSE

Purpose: Skin Moisturizing, Protection

WARNINGS

Warnings:
During the summer time store in refrigerator. and Place product at room temperature for else seasons. /
Not recommended for children under 4 years. / Expiration period: 2 years

KEEP OUT OF REACH OF CHILDREN

Not recommended for children under 4 years.

INDICATIONS & USAGE

Indications and Usage:
Spread thoroughly for full moisture.

DOSAGE & ADMINISTRATION

Dosage and Administration:
Take an adequate amount of this product.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

CLARA 1984
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69404-010
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	0.5 mg in 50 mL

Ingredient Name	Strength
Inactive Ingredients
Cinnamon (UNII: 5S29HWU6QB)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69404-010-01	50 mL in 1 CARTON

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	12/20/2014

Labeler - CLARA GROUP (689060172)

Registrant - CLARA GROUP (689060172)

Name	Address	ID/FEI	Business Operations
Establishment
CLARA GROUP		689060172	manufacture(69404-010)