HAND SANITIZER- hand sanitizer liquid 
NINGBO JIANGBEI OCEAN STAR TRADING 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.

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Active Ingredients

Active ingredients--------------purpose

Citric Acid，Sodium Laureth Sulfate，Coco Diethanolamide，Cocomidopropyl Betaine

Uses:
Reduces bacteria on the skin. Recommended for repeated use.

Warnings:

For external use only.Keep out of eyes.In case of eye contact immediately flush with water,call a doctor.If swallowed call a doctor.

Directions:

Rotate pump anti-clock wise to release the pump and press.

Other Information

Do not store above 110F(43C) May discolor certain fabric or surfaces. Harmful to wood finishes and plastics.


Children under 6 years of age should be super vised when using this product.

Inactive Ingredients:

Water,Fragrance,Sodium Chloride,Kathon,Disodium Edta

image of hand sanitizer

HAND SANITIZER 
hand sanitizer liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47993-204
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID0.3 g  in 100 g
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) (COCAMIDOPROPYL BETAINE - UNII:5OCF3O11KX) COCAMIDOPROPYL BETAINE5   in 100 g
Inactive Ingredients
Ingredient NameStrength
SODIUM LAURETH SULFATE (UNII: BPV390UAP0) 15 g  in 100 g
COCO DIETHANOLAMIDE (UNII: 92005F972D) 6 g  in 100 g
EDETIC ACID (UNII: 9G34HU7RV0) 1 g  in 100 g
SODIUM CHLORIDE (UNII: 451W47IQ8X) 2 g  in 100 g
AROMADENDRIN (UNII: 7YA4640575) 0.2 g  in 100 g
ISOTHIAZOLINONE (UNII: E57JT172V7) 0.3 g  in 100 g
WATER (UNII: 059QF0KO0R) 70.2   in 100 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:47993-204-01250 g in 1 BOTTLE; Type 0: Not a Combination Product09/26/2016
2NDC:47993-204-02300 g in 1 BOTTLE; Type 0: Not a Combination Product09/26/2016
3NDC:47993-204-03500 g in 1 BOTTLE; Type 0: Not a Combination Product09/26/2016
4NDC:47993-204-041000 g in 1 BOTTLE; Type 0: Not a Combination Product09/26/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35609/26/2016
Labeler - NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD (529334491)
Registrant - NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD (529334491)
Establishment
NameAddressID/FEIBusiness Operations
NINGBO OCEANSTAR CHEMICAL PRODUCTS CO.,LTD544493972manufacture(47993-204)

Revised: 12/2017
Document Id: 5fa964bb-55a7-1f45-e053-2a91aa0ad913
Set id: d167cd73-7e1b-476e-997a-0e15b07f8a28
Version: 2
Effective Time: 20171206
 
NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD