Hand Sanitizer by NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD / JIANGSU INTCO MEDICAL PRODUCTS CO.,LTD 47993-360

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD, JIANGSU INTCO MEDICAL PRODUCTS CO.,LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER- hand sanizizer gel 
NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD

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47993-360

Active ingredients

Ethyl Alcohol 62%

Antiseptic

Uses：

For hand sanitizing to reduce bacteria on the skin.

Warnings:

For external use only.

Flammable. Keep away from fire and flame.

When using this product ，do not use in or near the eyes.In case of contact，rinse eyes thoroughly with water.

Discontinue use if irritation or redness develops.

Keep out of reach of children.If swallowed，get medical help or contact a Poison Control Center right away.

Directions:

Squeeze small amount in your palm and briskly rub hands together until dry.

Inactive Ingredients:

Water，Glycerin，Carbomer，Fragrance，Triethanolamine，Aloe Barbadensis Leaf Juice，Vitamin E，Iron Oxide（CI77499),Iron Oxide(CI 77492),D&C Red No.30.

HAND SANITIZER 
hand sanizizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 47993-360
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 g  in 112 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 132584PQMO)
GLYCERIN (UNII: PDC6A3C0OX)
TROLAMINE (UNII: 9O3K93S3TK)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
D&C RED NO. 30 (UNII: 2S42T2808B)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 47993-360-01	15 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/15/2023
2	NDC: 47993-360-02	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/15/2023
3	NDC: 47993-360-03	54 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/15/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M	12/15/2023	07/21/2024

Labeler - NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD (529334491)

Registrant - NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD (529334491)

Establishment
Name	Address	ID/FEI	Business Operations
JIANGSU INTCO MEDICAL PRODUCTS CO.,LTD		529128686	manufacture(47993-360)

Revised: 7/2024

Document Id: 1dc01113-3ce3-8dc0-e063-6394a90a5dd7

34390-5

Set id: b19497de-dec5-48dd-b24e-4a96b05705cf

Version: 4

Effective Time: 20240721

 

NI