Label: BE SAFE- hand sanitizer gel
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Contains inactivated NDC Code(s)
NDC Code(s): 79815-111-11, 79815-111-12, 79815-111-13, 79815-111-14, view more79815-111-15, 79815-111-16 - Packager: AVID INTERNATIONAL FZE
- 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 29, 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. Do not inhale or ingest.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition. If condition persists for more than 72 hours.
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
BE SAFE
hand sanitizer gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79815-111 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 75 mL in 100 mL Inactive Ingredients Ingredient Name Strength CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208) GLYCERIN (UNII: PDC6A3C0OX) PEG-30 GLYCERYL COCOATE (UNII: FX3EB7VC3L) WATER (UNII: 059QF0KO0R) TROLAMINE (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79815-111-11 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/29/2020 2 NDC:79815-111-12 100 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/29/2020 3 NDC:79815-111-13 250 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/29/2020 4 NDC:79815-111-14 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/29/2020 5 NDC:79815-111-15 1000 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/29/2020 6 NDC:79815-111-16 3785 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/29/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 07/29/2020 Labeler - AVID INTERNATIONAL FZE (851719144) Establishment Name Address ID/FEI Business Operations STORY OF LOVE COSMETIC CO., LTD. 679768544 manufacture(79815-111)