ROSE PETALS SILKEN HAND SANITIZER WITH ALOE VERA

SILKEN HAND SANITIZER by

Drug Labeling and Warnings

SILKEN HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by COSMOBEAUTI LABORATORIES & MANUFACTURING, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SILKEN HAND SANITIZER- ethyl alcohol gel 
COSMOBEAUTI LABORATORIES & MANUFACTURING, 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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ROSE PETALS SILKEN HAND SANITIZER WITH ALOE VERA

ACTIVE INGREDIENTS

ETHYL ALCOHOL 70%

PURPOSE

ANTISEPTIC

DIRECTIONS

WET HANDS THOROUGHLY WITH PRODUCT AND ALLOW TO DRY WITHOOUT WIPING.

USES

FOR HANDWASHING TO DECREASE BACTERIA ON THE SKIN.

WARNINGS

• For external use only-hands.
• Flammable. Keep away from heat and flame. Do not store above 105°F.
• Keep out of eyes.
• Avoid contact with broken skin.
• Do not ingest or inhale.

• Keep out of reach of children. For children under 6, use only under adult supervision.
• In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

INACTIVE INGREDIENTS

ALOE BARBADENSIS (ALOE VERA) LEAF JUICE, AMINOMETHYL PROPANOL, CARBOMER, DISODIUM EDTA, GLYCERIN, ISOPROPYL MYRISTATE, PROPELENE GLYCOL, WATER (AQUA)

SILKEN HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69077-102
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69077-102-18	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020	04/02/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2020	04/02/2020

Labeler - COSMOBEAUTI LABORATORIES & MANUFACTURING, INC. (021687376)

Revised: 4/2020

Document Id: 78b0290c-bbfc-44c3-8a1f-d9008fdf79f8

34390-5

Set id: e2adb49b-9a10-4b1f-81ab-b9e494f8bdd0

Version: 2

Effective Time: 20200402

 

COSMOBEAUTI LABORATORIES & MANUFACTURING, INC.