anti-bacterial hand gel by Guangzhou Opseve Cosmetics Co., Ltd

anti-bacterial hand gel by

Drug Labeling and Warnings

anti-bacterial hand gel by is a Otc medication manufactured, distributed, or labeled by Guangzhou Opseve Cosmetics Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ANTI-BACTERIAL HAND GEL- hand sanitizer gel 
Guangzhou Opseve 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.

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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

  • in children less than 2 months of age
  • on open skin wounds

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

  • Take appropriate amount in your palm then cover all surfaces of your hands and rub them together until they feel dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

Sealed, stored in a cool, dry place, away from direct sunlight.

Inactive ingredients

carbomer, fragrance, glycerin, triethanolamine, water.

Package Label - Principal Display Panel

98 mL NDC: 77900-2024-1 Package LabelPackage LabelPackage LabelPackage Label

Package Label - Principal Display Panel

473 mL NDC: 77900-2024-2 Package LabelPackage Label

ANTI-BACTERIAL HAND GEL 
hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 77900-2024
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) 0.4 mL  in 100 mL
FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK) 0.1085 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 23.8915 mL  in 100 mL
CARBOMER 980 (UNII: 4Q93RCW27E) 0.35 mL  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK) 0.25 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 77900-2024-198 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/23/2020
2NDC: 77900-2024-2473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/23/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/23/202012/31/2022
Labeler - Guangzhou Opseve Cosmetics Co., Ltd (421275457)
Registrant - Guangzhou Opseve Cosmetics Co., Ltd (421275457)
Establishment
NameAddressID/FEIBusiness Operations
Guangzhou Opseve Cosmetics Co., Ltd421275457manufacture(77900-2024)

Revised: 3/2023