HAND SANITIZER- hand sanitizer gel 
GUANGZHOU RAINHOME PHARM&TECH 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 Ingredient(s)

Ethyl Alcohol 75% v/

Purpose

Antiseptic

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

keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water

if irritation or rash occurs. These may be signs of a serious condition.

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

Directions

Other information

Inactive ingredients

Water, C10 30 alkyl acrylate crosspolymer, aminomethyl propanol, glycerin, aloe barbadensis (leaf)extract

Package Label - Principal Display Panel

141841313812377261716211193033438422327352423228019153653922104131204029334256

HAND SANITIZER 
hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78126-007
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
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL  in 100 mL
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L) 0.4 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 24.05 mL  in 100 mL
AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.04 mL  in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.01 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78126-007-0120 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
2NDC:78126-007-0225 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
3NDC:78126-007-0330 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
4NDC:78126-007-0440 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
5NDC:78126-007-0550 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
6NDC:78126-007-0659 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
7NDC:78126-007-0760 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
8NDC:78126-007-0873 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
9NDC:78126-007-0980 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
10NDC:78126-007-10100 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
11NDC:78126-007-11106 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
12NDC:78126-007-12118 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
13NDC:78126-007-13120 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
14NDC:78126-007-14150 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
15NDC:78126-007-15200 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
16NDC:78126-007-16207 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
17NDC:78126-007-17220 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
18NDC:78126-007-18221 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
19NDC:78126-007-19237 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
20NDC:78126-007-20250 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
21NDC:78126-007-21296 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
22NDC:78126-007-22300 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
23NDC:78126-007-29500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
24NDC:78126-007-23350 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
25NDC:78126-007-24355 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
26NDC:78126-007-25400 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
27NDC:78126-007-26444 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
28NDC:78126-007-27450 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
29NDC:78126-007-28473 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
30NDC:78126-007-30532 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
31NDC:78126-007-31550 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
32NDC:78126-007-32800 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
33NDC:78126-007-33999 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
34NDC:78126-007-341000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
35NDC:78126-007-351479 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
36NDC:78126-007-362000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
37NDC:78126-007-372500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
38NDC:78126-007-383000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
39NDC:78126-007-393785 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
40NDC:78126-007-404000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
41NDC:78126-007-415000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
42NDC:78126-007-427571 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
43NDC:78126-007-4325000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
44NDC:78126-007-4450000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - GUANGZHOU RAINHOME PHARM&TECH CO., LTD (547018779)
Establishment
NameAddressID/FEIBusiness Operations
GUANGZHOU RAINHOME PHARM&TECH CO., LTD547018779manufacture(78126-007)

Revised: 5/2020
Document Id: a59ba5db-e674-b54e-e053-2995a90a27ce
Set id: a59ba5db-e682-b54e-e053-2995a90a27ce
Version: 1
Effective Time: 20200514
 
GUANGZHOU RAINHOME PHARM&TECH CO., LTD