HAND SANITIZER- hand sanitizer gel 
Sichuan Rejoy Essence Biotechnology 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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Active Ingredient(s)

Ethyl Alcohol 62% Purpose Antiseptic

Purpose

Purpose Antiseptic

Uses

Decreases Bacteria On Hands

WARNINGS

For External Use Only

When using this product

When using this product,do not use in or near the eyes.

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.

/

Keep out of reach of children

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

Directions

Squeeze onto hands and rub hands
together briskly until dry. Do Not Store Above
110°F Non-staining,may discolor certain fabrics

Other information

Do Not Store Above
110°F Non-staining,may discolor certain fabrics

Inactive ingredients

Deionized Water,Carbomer,Triethanolamine,
Aloe Barbadensis ,Ethanol,Glycerol,
Propylene Glycol,Vitamin E.

Package Label - Principal Display Panel

12

HAND SANITIZER 
hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74034-006
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
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TRICLOSAN (UNII: 4NM5039Y5X)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOMER 934 (UNII: Z135WT9208)  
WATER (UNII: 059QF0KO0R)  
TROLAMINE (UNII: 9O3K93S3TK)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74034-006-0110 mL in 1 BOTTLE; Type 0: Not a Combination Product04/17/2020
2NDC:74034-006-0220 mL in 1 BOTTLE; Type 0: Not a Combination Product04/17/2020
3NDC:74034-006-0330 mL in 1 BOTTLE; Type 0: Not a Combination Product04/17/2020
4NDC:74034-006-0554 mL in 1 BOTTLE; Type 0: Not a Combination Product04/17/2020
5NDC:74034-006-06100 mL in 1 BOTTLE; Type 0: Not a Combination Product04/17/2020
6NDC:74034-006-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product04/17/2020
7NDC:74034-006-09500 mL in 1 BOTTLE; Type 0: Not a Combination Product04/17/2020
8NDC:74034-006-0450 mL in 1 BOTTLE; Type 0: Not a Combination Product04/17/2020
9NDC:74034-006-07100 mL in 1 BOTTLE; Type 0: Not a Combination Product04/17/2020
10NDC:74034-006-101000 mL in 1 BOTTLE; Type 0: Not a Combination Product04/17/2020
11NDC:74034-006-1160 mL in 1 BOTTLE; Type 0: Not a Combination Product04/17/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/17/2020
Labeler - Sichuan Rejoy Essence Biotechnology Co., Ltd (407046287)
Establishment
NameAddressID/FEIBusiness Operations
Sichuan Rejoy Essence Biotechnology Co., Ltd407046287manufacture(74034-006)

Revised: 5/2020
Document Id: a4f80dfd-0dc5-88a3-e053-2a95a90af8e6
Set id: a4df83a9-1ba9-341e-e053-2a95a90a346a
Version: 2
Effective Time: 20200506
 
Sichuan Rejoy Essence Biotechnology Co., Ltd