HAND SANITIZER- ethyl alcohol gel 
Hemani International

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The hand sanitizer is manufactured using only the following ingredients in the preparation of the product (percentage in final product formulation):

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v))
  2. Sterile distilled water or boiled cold water.
  3. Glycerol (5% v/v).
  4. Carbomer Copolymer Type A (Allyl Pentaerythritol Crosslinked)(1.5% v/v).
  5. Propylene Glycol (1% v/v).
  6. Fragrance (Dimethyl Anthranilate) (0.5% v/v).
  7. Triethanolamine (0.15% v/v).
  8. Dexpanthenol (Panthenol) (0.10% v/v).
  9. Aloe Barbadensis Leaf Juice Powder (0.05% v/v).
  10. Beads (Mannitol, Microcrystalline Cellulose, Hydroxypropyl Methylcellulose, Pigment Green 7 (CI 74260) (0.02% v/v).
  11. Blue 1 (CI 42090) (0.005% v/v).

The firm does not add other active or inactive ingredients besides listed above.

Active Ingredient(s)

Ethyl Alcohol 80% 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

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

Other information

Inactive ingredients

water (aqua), glycerin (glycerol), Carbomer Copolymer Type A (Allyl Pentaerythritol Crosslinked), propylene glycol, Fragrance (Dimethyl Anthranilate), Triethanolamine, Dexpanthenol (Panthenol), Aloe Barbadensis Leaf Juice Powder, Beads [(Mannitol, Microcrystalline Cellulose, Hydroxypropyl Methylcellulose, Pigment Green 7 (CI 74260)], Blue 1 (CI 42090)

Package Label - Principal Display Panel

​50 mL NDC: 75360-1125-1

65 mL NDC: 75360-1125-2

100 mL NDC: 75360-1125-3

250 mL NDC: 75360-1125-4

1 L NDC: 75360-1125-5

500 mL NDC: 75360-1125-6

50 mL Label65 mL Label100 mL Label250 mL Label1L Label

500mL Label

HAND SANITIZER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75360-1125
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 0.005 mL  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK) 0.15 mL  in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.05 mL  in 100 mL
DIMETHYL ANTHRANILATE (UNII: 5Z37T562P9) 0.5 mL  in 100 mL
MANNITOL (UNII: 3OWL53L36A)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
PIGMENT GREEN 7 (UNII: BPO9294G4W)  
DEXPANTHENOL (UNII: 1O6C93RI7Z) 0.1 mL  in 100 mL
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L) 1.5 mL  in 100 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 1 mL  in 100 mL
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
GLYCERIN (UNII: PDC6A3C0OX) 5 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 11.68 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75360-1125-150 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2020
2NDC:75360-1125-265 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2020
3NDC:75360-1125-4250 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2020
4NDC:75360-1125-51000 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2020
5NDC:75360-1125-3100 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2020
6NDC:75360-1125-6500 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2020
7NDC:75360-1125-7400 mL in 1 BAG; Type 0: Not a Combination Product04/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph Drug505G(a)(3)04/01/2020
Labeler - Hemani International (645581294)
Registrant - Hemani International (645581294)
Establishment
NameAddressID/FEIBusiness Operations
Hemani International645581294manufacture(75360-1125)

Revised: 12/2023
Document Id: 0ce04f31-95fa-4ebe-e063-6394a90a7832
Set id: a3bc102f-0403-8854-e053-2995a90ad004
Version: 7
Effective Time: 20231219
 
Hemani International