CARLOTTA INSTANT HAND SANITIZER- alcohol gel
Guangzhou Zuofun 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.
Carlotta Instant Hand Sanitizer
Drug Facts
Active ingredient
Ethyl alcohol 75%ï¼V/V)
Purpose
Antiseptic
Use
for handwashing to decrease bacteria on the hand
Warnings
For external use only..
Flammable, keep away from fire or flame.
Do not use
in the eyes.
Stop use and ask a doctor if
irritation and redness develop
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
Wet hands thoroughly with product and allow to
Other Information
Store between 59-86°F (15-30°C)
Avoid freezing and excessive heat above 104°F (40°C)
Inactive ingredients
Carbomer, Glycerol, Triethanolamine, Water.
Package Labeling: 250ml
Label
Package Labeling: 500ml
Label2
Package Labeling: 4.9L
Label 4.9
Package Labeling: 300ml
Bottle2
Package Labeling: 100ml
Bottle3
Package Labeling: 60ml
Bottle4
Package Labeling: Tube, 60ml
Bottle5
Package Labeling:Go, 60ml
Bottle6
Package Labeling: 960ml Bottle
Label960
Package Labeling:120ml
Label120
Package Labeling:236ml
Label236
Package Labeling:3.8L
Label3.8
CARLOTTA INSTANT HAND SANITIZER
alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:77027-000
Route of Administration TOPICAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 0.75 mL in 1 mL
Inactive Ingredients
Ingredient Name Strength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
GLYCERIN (UNII: PDC6A3C0OX)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
Packaging
Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:77027-000-01 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/01/2020
2 NDC:77027-000-02 250 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/01/2020
3 NDC:77027-000-03 4900 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/24/2020
4 NDC:77027-000-04 300 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/24/2020
5 NDC:77027-000-05 100 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/24/2020
6 NDC:77027-000-06 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/24/2020
7 NDC:77027-000-07 60 mL in 1 TUBE; Type 0: Not a Combination Product 05/24/2020
8 NDC:77027-000-08 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/24/2020
9 NDC:77027-000-09 960 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/18/2020
10 NDC:77027-000-10 120 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/13/2020
11 NDC:77027-000-11 236 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/13/2020
12 NDC:77027-000-12 3800 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/01/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 05/01/2020
Labeler - Guangzhou Zuofun Cosmetics Co., Ltd (530135094)
Revised: 7/2020
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