OTC Medication Information: Gothan Grape Scented Hand Sanitizer 01

GOTHAN GRAPE SCENTED HAND SANITIZER 01- alcohol gel
Foshan Astar Industry 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.

Active ingredient Purpose

Alcohol Denat. 70%(v/v)….. Antibacterial

Use

To decrease bacteria on the skin that could cause disease.

Warnings

For external use only.

Flammable. Keep away from fire or flame.

When using this product

  • Keep out of eyes.
  • Avoid contact with broken skin.

Stop use and ask a doctor if

  • Irritation or redness develops.

Keep out of reach of children

  • Do not inhale or ingest
  • if swallowed, get medical help or contact a poison control center right away.

Direction

Rub a dime sized drop into hands.

For children under 8 use under adult supervision

Inactive ingredients

WATER(AQUA/EAU), PEG-40 HYDROGENATED CASTOR OIL, FRAGRANCE( PARFUM), ACRYLATES/ C10-30 ALKYL ACRYLATE CROSSPOLYMER, TRIETHANOLAMINE.
MAY CONTAIN: FD&C YELLOW NO. 5( CI19140), FD&C RED NO. 40( CI16035), FD&C BLUE NO.1(CI 42090), D&C RED NO. 33( CI 17200).

Questions?

1-212-779-0544 weekdays

77901-035-01
(click image for full-size original)

GOTHAN GRAPE SCENTED HAND SANITIZER 01
alochol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:77901-035
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 70 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
TROLAMINE 0.16 g in 100 mL
WATER 36.2397 g in 100 mL
GRAPE 0.2 g in 100 mL
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) 0.2 mL in 100 mL
POLYOXYL 40 HYDROGENATED CASTOR OIL 0.2 mL in 100 mL
FD&C BLUE NO. 1 0.0003 g in 100 mL
Product Characteristics
Color blue Score
Shape Size
Flavor GRAPE Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:77901-035-01 59 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 06/19/2020
Labeler — Foshan Astar Industry Co., Ltd (421358695)
Registrant — Foshan Astar Industry Co., Ltd (421358695)
Establishment
Name Address ID/FEI Operations
Foshan Astar Industry Co., Ltd 421358695 manufacture (77901-035)

Revised: 04/2021 Foshan Astar Industry Co., Ltd

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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