75% ALCOHOL HAND SANITIZER WITH ALOE VERA- hand sanitizer gel 
Guangdong Kang Rong Industrial 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)

Alcohol 75% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

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

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.

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.

Directions

Other information

Inactive ingredients

aloe, carbomer, glycerin, sterile distilled water, triethanolamine.

Package Label - Principal Display Panel

50 mL NDC: 76616-050-05 Package Label

Package Label - Principal Display Panel

500 mL NDC: 76616-050-04 Package Label

75% ALCOHOL HAND SANITIZER WITH ALOE VERA 
hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76616-050
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
ALOE (UNII: V5VD430YW9) 0.15 mL  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK) 0.4 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL  in 100 mL
CARBOMER 940 (UNII: 4Q93RCW27E) 0.4 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 23.55 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76616-050-0550 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/06/2020
2NDC:76616-050-04500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/06/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/06/2020
Labeler - Guangdong Kang Rong Industrial Co., Ltd. (560529816)
Registrant - Guangdong Kang Rong Industrial Co., Ltd. (560529816)
Establishment
NameAddressID/FEIBusiness Operations
Guangdong Kang Rong Industrial Co., Ltd.560529816manufacture(76616-050)

Revised: 7/2020
Document Id: a9c319e8-2158-309d-e053-2a95a90a7571
Set id: a9c319d2-a727-cd89-e053-2995a90ac3f5
Version: 1
Effective Time: 20200706
 
Guangdong Kang Rong Industrial Co., Ltd.