Label: INSTANT HAND SANITIZER- hand sanitizer gel
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Contains inactivated NDC Code(s)
NDC Code(s): 77976-001-95 - Packager: Whealth Lohmann Centralin (GZ) 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 July 10, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient(s)
- Purpose
- Use
- Warnings
- Do not use
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WHEN USING
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. If swallowed, get medical help or contact a Poison Control Center right away. - STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
INSTANT HAND SANITIZER
hand sanitizer gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77976-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 343.2 mL in 520 mL Inactive Ingredients Ingredient Name Strength FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK) 0.104 mL in 520 mL TROLAMINE (UNII: 9O3K93S3TK) 0.884 mL in 520 mL GLYCERIN (UNII: PDC6A3C0OX) 5.2 mL in 520 mL CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208) 1.3 mL in 520 mL WATER (UNII: 059QF0KO0R) 169.312 mL in 520 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77976-001-95 520 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 05/28/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/28/2020 Labeler - Whealth Lohmann Centralin (GZ) Co., Ltd (545350568) Registrant - Whealth Lohmann Centralin (GZ) Co., Ltd. (545350568) Establishment Name Address ID/FEI Business Operations Whealth Lohmann Centralin (GZ) Co., Ltd. 545350568 manufacture(77976-001)