Hand Sanitizer Gel by Dongyang Medical & Hygienic Articles Co., Ltd. / Dongyang Medical & Hygienic Articles Co., Ltd. 53031-018 100ml 70%

Hand Sanitizer Gel by

Drug Labeling and Warnings

Hand Sanitizer Gel by is a Otc medication manufactured, distributed, or labeled by Dongyang Medical & Hygienic Articles Co., Ltd., Dongyang Medical & Hygienic Articles Co., Ltd. . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER GEL- hand sanitizer gel gel 
Dongyang Medical & Hygienic Articles 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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53031-018 100ml 70%

Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

To decrease bacteria on the skin that could cause disease.

Recommended for repeated use.

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

keep out of eyes. In case of contact with eyes, flush thoroughly with water.

avoid contact with broken skin.

do not inhale or ingest.

Stop use and ask a doctor if irritation or redness develops.

condition persists for more than 72 hours.

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

Directions

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

  • Do not store above 105F
  • May discolor some fabrics.
  • Harmful to wood finishes and plastics.

Inactive ingredients

AMINOMETHYLPROPANOL ,CARBOMER,GLYCERIN ,PROPYLENE GLYCOL, WATER

Package Label - Principal Display Panel

100 ml in 1 BOTTLE NDC: 53031-018-01

100 ml label

HAND SANITIZER GEL 
hand sanitizer gel gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 53031-018
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CARBOMER 980 (UNII: 4Q93RCW27E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 53031-018-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/202011/23/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/202011/23/2020
Labeler - Dongyang Medical & Hygienic Articles Co., Ltd. (530310429)
Registrant - Dongyang Medical & Hygienic Articles Co., Ltd. (530310429)
Establishment
NameAddressID/FEIBusiness Operations
Dongyang Medical & Hygienic Articles Co., Ltd. 530310429manufacture(53031-018)

Revised: 11/2020
 
Dongyang M

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