Label: WHITESTONE DOME LIFE HAND SANITIZER- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 76941-100-01, 76941-101-01 - Packager: White Stone, Ltd.
- 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 April 28, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
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Warnings
For external use only. Flammable. Keep away from heat or flame
Do not use
· in children less than 2 months of age
· on open skin wounds
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
- Keep out of reach of children
- Directions
- Inactive ingredients
- Whitestone dome life hand sanitizer
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INGREDIENTS AND APPEARANCE
WHITESTONE DOME LIFE HAND SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76941-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 74.18 mL in 100 mL Inactive Ingredients Ingredient Name Strength .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) WATER (UNII: 059QF0KO0R) TROLAMINE (UNII: 9O3K93S3TK) DIPROPYLENE GLYCOL (UNII: E107L85C40) HYALURONIC ACID (UNII: S270N0TRQY) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76941-101-01 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/28/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 04/28/2020 WHITESTONE DOME LIFE HAND SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76941-100 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 74.18 mL in 100 mL Inactive Ingredients Ingredient Name Strength .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) WATER (UNII: 059QF0KO0R) TROLAMINE (UNII: 9O3K93S3TK) DIPROPYLENE GLYCOL (UNII: E107L85C40) HYALURONIC ACID (UNII: S270N0TRQY) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76941-100-01 100 mL in 1 TUBE; Type 0: Not a Combination Product 04/28/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 04/28/2020 Labeler - White Stone, Ltd. (690342449) Establishment Name Address ID/FEI Business Operations JUHWANBIO. CELL CO.,LTD. 690163444 manufacture(76941-100, 76941-101)
