Label: PROTECT BY HAND SANITIZER WATER (ETHANOL)- ethyl ethanol liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 74674-0006-1 - Packager: Skin n Skin Co., 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 September 15, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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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 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. If swallowed, get medical help or contact a Poison Control Center right away.
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PROTECT BY HAND SANITIZER WATER (ETHANOL)
ethyl ethanol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:74674-0006 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 35 mL in 50 mL Inactive Ingredients Ingredient Name Strength ORANGE OIL (UNII: AKN3KSD11B) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) CHAMOMILE (UNII: FGL3685T2X) ROSA CENTIFOLIA FLOWER OIL (UNII: H32V31VMWY) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:74674-0006-1 50 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 09/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 09/01/2020 Labeler - Skin n Skin Co., Ltd. (631090037) Registrant - Skin n Skin Co., Ltd. (631090037) Establishment Name Address ID/FEI Business Operations Skin n Skin Co., Ltd. 631090037 manufacture(74674-0006) , label(74674-0006) , pack(74674-0006)
