HAND SANITIZER 01- hand sanitizer gel gel 
Yiwu Shining Cosmetics 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.

----------

74862-008
Hand sanitizer gel

Active ingredient Purpose

Ethyl Alcohol 62%

Antiseptic

For handwashing to decrease bacteria on the skin

Flammable, keep away from fire or flame.
For external use only.

Do not use near eyes.
In case of contact, flush eyes with water.

Stop use and ask a doctor
If redness or irritation develop and persist for more than 72 hours.

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

Do not use near eyes.
In case of contact, flush eyes with water.

Do not use near eyes.
In case of contact, flush eyes with water.

Stop use and ask a doctor
If redness or irritation develop and persist for more than 72 hours.

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 redness or irritation develop and persist for more than 72 hours.

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

Place a palmful (5 grams) of product in one hand.
Spread on both hands and rub into skin until dry (1-2 min.).
Place a smaller amount (2.5 grams) into one hand, spread overboth hands to wrist and rub into the skin until dry.
Children must be supervised in the use of this product

/

Inactive ingredients

Aloe Barbadensis Leaf Juice, Carbomar, Fragrance, Glycerin, Propylene Glycol, Triethanolamine.

74862-008-01 29ml

74862-008-01 29ml

74862-008-02 30ml

74862-008-02 30ml

74862-008-03 59ml

74862-008-03 59ml

74862-008-04 60ml

74862-008-04 60ml

74862-008-05 100ml

74862-008-05 100ml

74862-008-06 120ml

74862-008-06 120ml

74862-008-07 180ml

74862-008-07 180ml

74862-008-08 240ml

74862-008-08 240ml

74862-008-09 300ml

74862-008-09 300ml

74862-008-10 500ml

74862-008-10 500ml

HAND SANITIZER  01
hand sanitizer gel gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74862-008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74862-008-0129 mL in 1 BOTTLE; Type 0: Not a Combination Product06/19/2020
2NDC:74862-008-0359 mL in 1 BOTTLE; Type 0: Not a Combination Product06/19/2020
3NDC:74862-008-0460 mL in 1 BOTTLE; Type 0: Not a Combination Product06/19/2020
4NDC:74862-008-05100 mL in 1 BOTTLE; Type 0: Not a Combination Product06/19/2020
5NDC:74862-008-06120 mL in 1 BOTTLE; Type 0: Not a Combination Product06/19/2020
6NDC:74862-008-0230 mL in 1 BOTTLE; Type 0: Not a Combination Product06/19/2020
7NDC:74862-008-08240 mL in 1 BOTTLE; Type 0: Not a Combination Product06/19/2020
8NDC:74862-008-09300 mL in 1 BOTTLE; Type 0: Not a Combination Product06/19/2020
9NDC:74862-008-10500 mL in 1 BOTTLE; Type 0: Not a Combination Product06/19/2020
10NDC:74862-008-07180 mL in 1 BOTTLE; Type 0: Not a Combination Product06/19/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/19/2020
Labeler - Yiwu Shining Cosmetics Co.,Ltd (543002719)
Establishment
NameAddressID/FEIBusiness Operations
Yiwu Shining Cosmetics Co.,Ltd543002719manufacture(74862-008)

Revised: 1/2021
Document Id: b950ae38-3976-6f21-e053-2a95a90a2be5
Set id: b950ae38-3975-6f21-e053-2a95a90a2be5
Version: 1
Effective Time: 20210120
 
Yiwu Shining Cosmetics Co.,Ltd