HAND SANITIZER- ethyl alcohol gel

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
Available from:
Nantong Health & Beyond Hygienic Products Inc.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Purpose Antiseptic Uses for handwashing to decrease bacteria on the skin. Stop use and ask a doctor if - irritation and redness develop. - condition persists for more than 72 hours
Authorization status:
OTC monograph not final
Authorization number:
43473-105-01

HAND SANITIZER- ethyl alcohol gel

Nantong Health & Beyond Hygienic Products Inc.

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

Alcohol 67%

Purpose

Antiseptic

Uses

for handwashing to decrease bacteria on the skin.

Warnings

For external use only. Flammable, keep away from fire or flame.

Do not use in the eyes.In case of contact, flush eyes with water.

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 hand thoroughly with product and allow to dry without wiping

Other information

store at a temperature below 110 F(43 C)

Inactive ingredients

water(aqua), aloe vera leaf juice, glycerin, propylene glycol, fragrance(parfum), acrylates/C30-10 alkyl

acrylate crosspolymer, aminomethyl propanol, mannitol, microcrystalline cellulose, sucrose, corn(zea

mays) starch, hydroxpropyl methyl cellulose, tocopheryl acetate, denatonium benzonate, maltodextrin,

benzyl benzoate, hexyl cinnamal, limonene, linalool, Ferric Ferrocyanide, D&C Red No.30, D&C Red

No.33, FD&C Blue No.1.

HAND SANITIZER

ethyl alcohol gel

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:43473-10 5

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ALCO HO L (UNII: 3K9 9 58 V9 0 M) (ALCOHOL - UNII:3K9 9 58 V9 0 M)

ALCOHOL

6 7 mL in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

D&C RED NO . 3 0 (UNII: 2S42T28 0 8 B)

LIMO NENE, ( +) - (UNII: GFD7C8 6 Q1W)

BENZYL BENZO ATE (UNII: N8 6 3NB338 G)

FERRIC FERRO CYANIDE (UNII: TLE29 4X33A)

DENATO NIUM BENZO ATE (UNII: 4YK5Z54AT2)

MALTO DEXTRIN (UNII: 7CVR7L4A2D)

.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6 O37OK2I)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

MANNITO L (UNII: 3OWL53L36 A)

WATER (UNII: 0 59 QF0 KO0 R)

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

GLYCERIN (UNII: PDC6 A3C0 OX)

CARBO MER INTERPO LYMER TYPE A ( 550 0 0 CPS) (UNII: 59 TL3WG5CO)

AMINO METHYLPRO PANO L (UNII: LU49 E6 6 26 Q)

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

SUCRO SE (UNII: C151H8 M554)

STARCH, CO RN (UNII: O8 232NY3SJ)

.ALPHA.-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )

HYPRO MELLO SES (UNII: 3NXW29 V3WO)

D&C RED NO . 3 3 (UNII: 9 DBA0 SBB0 L)

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

LINALO O L, ( +) - (UNII: F4VNO44C0 9 )

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:43473-10 5-0 1

30 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 2/18 /20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt333E

0 2/18 /20 19

Labeler -

Nantong Health & Beyond Hygienic Products Inc. (421280161)

Nantong Health & Beyond Hygienic Products Inc.

Revised: 3/2019

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