Hand Sanitizer Gel: Package Insert and Label Information

HAND SANITIZER GEL- alcohol gel
Jinda Nano Tech.(Xiamen) 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.

Alcohol 70% v/v. Purpose: Antiseptic

Active ingredient
(click image for full-size original)

Purpose

Antiseptic, Hand Sanitizer Purpose

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available. Use

Warnings

For external use only. Flammable. Keep away from heat or flame Warnings

Do not use

  • in children less than 2 months of age
  • on open skin wounds Do not use
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. Stop use and ask a doctor

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

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. Directions
Directions

Other information

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F) Other information
Other information

Inactive ingredients

carbomer, sterile distilled water Inactive ingredients

Package Label — Principal Display Panel

250 mL NDC: 77974-2020-1 Package Label

HAND SANITIZER GEL
hand sanitizer gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:77974-2020
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 175 mL in 250 mL
Inactive Ingredients
Ingredient Name Strength
CARBOMER 940 1.25 mL in 250 mL
WATER 73.75 mL in 250 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:77974-2020-1 250 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 05/18/2020
Labeler — Jinda Nano Tech.(Xiamen) Co., Ltd. (529408654)
Registrant — Jinda Nano Tech.(Xiamen) Co., Ltd. (529408654)
Establishment
Name Address ID/FEI Operations
Jinda Nano Tech.(Xiamen) Co., Ltd. 529408654 manufacture (77974-2020)

Revised: 05/2020 Jinda Nano Tech.(Xiamen) Co., Ltd.

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