COSMOBEAUTI - ROSE PETALS SILKEN INSTANT HAND SANITIZER SPRAY (69077-104) - DELIST

SILKEN INSTANT HAND SANITIZER by

Drug Labeling and Warnings

SILKEN INSTANT 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 INSTANT HAND SANITIZER- isopropyl alcohol spray 
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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COSMOBEAUTI - ROSE PETALS SILKEN INSTANT HAND SANITIZER SPRAY (69077-104) - DELIST

ACTIVE INGREDIENTS

ISOPROPYL ALCOHOL 70%

PURPOSE

ANTISEPTIC

DIRECTIONS

HOLD THE SPRAY UPRIGHT AND SPRAY FROM A DISTANCE OF 2 TO 4 INCHES. ADULTS AND CHILDREN: SPRAY ONTO THE AFFECTED AREA, AND FLOOD TO WASH AWAY DEBRIS AND DIRT. REAPPLY UP TO 2 TO 3 TIMES A DAY.

USES

LEAVES HANDS FEELING SOFT. KILLS MORE THAN 99.9% OF GERMS

WARNINGS

FOR USE ON THE SKIN ONLY.

• 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

WATER (AQUA), FRAGRANCE, ALOE BARBADENSIS (ALOE VERA) LEAF EXTRACT

SILKEN INSTANT HAND SANITIZER 
isopropyl alcohol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69077-104
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69077-104-12	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020	12/31/2021
2	NDC: 69077-104-16	200 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020	12/31/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/01/2020	12/31/2021

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

Revised: 3/2023

Document Id: f67cc70f-fc1c-4973-e053-2a95a90adce7

34390-5

Set id: 49de9157-904a-497d-a879-7613d101d1ae

Version: 3

Effective Time: 20230309

 

COSMOBEAUT