ADVANCED HAND SANITIZER- hand sanitizer liquid 
Dongguang Shuoguo Silicone Products Co., Ltd.

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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Smarties 1 oz Hand Sanitizer: Strawberry

Drug Facts

Active Ingredient

Ethyl Alcohol 65.0%

Purpose

Antiseptic

Uses

Hand Santizer to help reduce bacteria on skin that may cause disease.

Warnings

Flammable. Keep away from heat or flame.

For external use only.

Keep out of reach of children.

When using this product,

do not use in or near the eyes. In case of contact, rinse eyes thoroughtly with water. Stop use and ask doctor if irritation or rash appears and lasts. Keep out of reach for children.

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

Directions:

. Place enough Product in your palm to thoroughtly spread on both hands and rub into the skin until dry.

. Children under 6 years of age should be supervised when using this product.

Other Information:

. Store below 106℉. (41℃)

Inactive Ingredients:

Water (Aqua), Carbomer triethanolamine, Fragrance Red 33, Glycerin, Propylene Glycol, Yellow 5

Other

ADVANCED HAND SANITIZER 
hand sanitizer liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70939-211
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70939-211-0130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/01/2019
Labeler - Dongguang Shuoguo Silicone Products Co., Ltd. (544426629)

Revised: 11/2019
Document Id: 982214d5-74a8-5bf7-e053-2995a90a2c5a
Set id: d63262fc-1b48-4417-a7ea-136cd043f6f1
Version: 2
Effective Time: 20191124
 
Dongguang Shuoguo Silicone Products Co., Ltd.