HAND SANITIZER- hand sanitizer gel 
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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47993-225

Active ingredients

Ethyl Alcohol 68%

Antiseptic

Warnings:

For external use only-hands.Flammable.Keep away from heat and flame. Keep out of reach of children.

In case of accidental

ingestion,seek professional assistance or contact a Poison Control Center immediately

Stop use and ask a doctor if skin irritation develops.

Uses:

To decrease bacteria and germs on the skin.
Recommended for repeated use.

Directions:

Wet hands thoroughly with product and allow to dry without wiping.
For children under 6,use only under adult supervision.
Not recommended for infants.

Keep out of reach of children. For children under 6,use only under adult supervision.

Do not store above 105 ℉
May discolor some fabrics
Harmful to wood finishes and plastics

Inactive Ingredients:

Water(Aqua),Carbomer,Triethanolamine,Glycerin and Fragrance

236ml

236ml-2

485ml

485ml-2

88ml-1

88ml-2

HAND SANITIZER 
hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47993-225
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL68 g  in 112 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 13.8 g  in 112 mL
CARBOMER 940 (UNII: 4Q93RCW27E) 12 g  in 112 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X) 1 g  in 112 mL
TRIETHANOLAMINE BENZOATE (UNII: M3EN4GC19W) 3 g  in 112 mL
GLYCERIN (UNII: PDC6A3C0OX) 2 g  in 112 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:47993-225-01236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/09/2020
2NDC:47993-225-02485 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/09/2020
3NDC:47993-225-0388.7 mL in 1 TUBE; Type 0: Not a Combination Product04/09/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/09/2020
Labeler - NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD (529334491)
Registrant - NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD (529334491)

Revised: 11/2020
Document Id: b33facee-313f-40ae-e053-2995a90a6c2e
Set id: a2d6863c-2842-ef0d-e053-2995a90a33c1
Version: 5
Effective Time: 20201103
 
NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD