WeCool Toys Hand Sanitizer - Honey Suckle by WeCool Toys / Landy

WeCool Toys Hand Sanitizer - Honey Suckle by

Drug Labeling and Warnings

WeCool Toys Hand Sanitizer - Honey Suckle by is a Otc medication manufactured, distributed, or labeled by WeCool Toys, Landy. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WECOOL TOYS HAND SANITIZER - HONEY SUCKLE- alcohol liquid 
WeCool Toys

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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Active Ingredient(s)

Alcohol 62% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

• in children less than 2 months of age
• on open skin wounds

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Place enough product on hands to cover all surfaces. Rub hands together until dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

Acrylates/C10-30 alkyl acrylate crosspolyme

Ascorbyl palmitate

CI 77492

Deionized Water

Ethanol (≥95%)
Glycerin

Lactose
Fragrance - Honey

Hydroxypropyl methylcellulose

Jojoba esters

Lactose
Microcrystalline Celluose

Tocopheryl acetate
Triethanolamine

Red 4 (CI 14700
Yellow 5 (CI 19140)

Package Label - Principal Display Panel

250 mL NDC: 77006-076-01

WECOOL TOYS HAND SANITIZER - HONEY SUCKLE 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77006-076
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	145.9 g  in 250 mL

Inactive Ingredients
Ingredient Name	Strength
DRY BIOCELLULOSE (MW 2000000) (UNII: C8DF2GF8L2)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
GLYCERIN (UNII: PDC6A3C0OX)
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
WATER (UNII: 059QF0KO0R)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
TROLAMINE (UNII: 9O3K93S3TK)
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)
HYDROLYZED JOJOBA ESTERS (POTASSIUM SALTS) (UNII: CH428W5O62)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77006-076-01	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/18/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	11/18/2020	12/01/2020

Labeler - WeCool Toys (080480202)

Registrant - WeCool Toys (080480202)

Establishment
Name	Address	ID/FEI	Business Operations
Landy		545291775	manufacture(77006-076) , label(77006-076) , pack(77006-076)

Revised: 1/2022

Document Id: d567d005-edcb-3c62-e053-2995a90ac042

34390-5

Set id: b46a3046-a76c-a642-e053-2995a90a0386

Version: 3

Effective Time: 20220112