Label: ARIAS ANTISEPTIC HAND SANITIZER- ethyl alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 76603-100-03, 76603-100-05, 76603-100-06, 76603-100-10, view more76603-100-25, 76603-100-30, 76603-100-50 - Packager: Scentials Beautycare And Wellness Private Limited
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated July 11, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Purpose
- Uses
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Warnings
Flammable, keep away from fire/flame
For external use only
Do not use
• in children less than 2 months of age
• on open skin wounds
When using this product • do not get into eyes. In case of contact, rinse eyes thoroughly with water
Stop use and ask a doctor if
• irritation and redness develop
• condition persists for more than 72 hours
- Directions
- Other information
- Inactive ingredients
- Questions?
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SPL UNCLASSIFIED SECTION
LARA DUTTA
REFRESHING GEL
With Moisturizers, Vitamin E & Aloe Vera Extract
Distributed By: SCENTIALS BEAUTYCARE & WELLNESS PVT. LTD.
1001/1002, LOTUS GRANDEUR, OFF VEERA DESAI ROAD, ANDHERI WEST,
MUMBAI 400053, INDIA.
MADE IN INDIA
care@scentialsworld.com
www.scentialsworld.com
scentials_world @scentialsworld
Arias is the registered trademark of Arias Branding LLP.
Imitation of Graphics/Pack Design is a punishable offence.
- Packaging
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INGREDIENTS AND APPEARANCE
ARIAS ANTISEPTIC HAND SANITIZER
ethyl alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76603-100 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 72 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) DIETHYL PHTHALATE (UNII: UF064M00AF) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) TROLAMINE (UNII: 9O3K93S3TK) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ALOE VERA LEAF (UNII: ZY81Z83H0X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76603-100-03 30 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/15/2020 2 NDC:76603-100-05 50 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/15/2020 3 NDC:76603-100-06 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/15/2020 4 NDC:76603-100-10 100 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/15/2020 5 NDC:76603-100-25 250 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/15/2020 6 NDC:76603-100-30 300 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/15/2020 7 NDC:76603-100-50 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/15/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/15/2020 Labeler - Scentials Beautycare And Wellness Private Limited (861188203) Establishment Name Address ID/FEI Business Operations S.P.Y. AGRO INDUSTRIES LIMITED 676197931 manufacture(76603-100) Establishment Name Address ID/FEI Business Operations Guangzhou Zuofun Cosmetics Co., Ltd 530135094 manufacture(76603-100)