HAND SANITIZER- hand sanitizer gel 
Guangdong Shuchang daily necessities 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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Hand SANITIZER

Active Ingredients

Ethyl Alcohol 75%

Purposes

Antiseptic

Uses

Warnings

For external use only:hands

Flammable, keep away from fire or flame.

When using this product

Keep out of eyes.In case of contact with eyes,flush thoroughly with water.

Avoid contact with broken skin.Do not

Keep out of reach of children

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

Directions

Put a thumbnail size amount in your palm and rub your hands together briskly until dry.Children under 6 years of age should be supervised when using SMART CARE HAND SANITIZER,Not recommended for infants.

Other Information

Do not store above 100°F(38℃).

May discolor some fabrics.

Harmful to wood finishes and plastics.

Inactive Ingredients

WATER, CARBOMER, GLYCERIN, PROPYLENE GLYCOL,AMINOMETHYL PROPANOL, ALOE VERA EXTRACT.

Package Label - Principal Display Panel

59 ml label 80 ml label 300 ml label 500 ml label

HAND SANITIZER 
hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75442-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75442-001-0159 mL in 1 BOTTLE; Type 0: Not a Combination Product04/23/2020
2NDC:75442-001-0280 mL in 1 BOTTLE; Type 0: Not a Combination Product04/23/2020
3NDC:75442-001-03300 mL in 1 BOTTLE; Type 0: Not a Combination Product04/23/2020
4NDC:75442-001-04500 mL in 1 BOTTLE; Type 0: Not a Combination Product04/23/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/23/2020
Labeler - Guangdong Shuchang daily necessities Co., Ltd. (419899362)
Registrant - Guangdong Shuchang daily necessities Co., Ltd. (419899362)
Establishment
NameAddressID/FEIBusiness Operations
Guangdong Shuchang daily necessities Co., Ltd.419899362manufacture(75442-001)

Revised: 4/2020
Document Id: a3f322ab-cdad-ffee-e053-2a95a90ab65d
Set id: a3f32237-ba66-c1a0-e053-2995a90ad6ee
Version: 1
Effective Time: 20200423
 
Guangdong Shuchang daily necessities Co., Ltd.