Label: HAND SANITIZER gel
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Contains inactivated NDC Code(s)
NDC Code(s): 74658-002-01, 74658-002-02, 74658-002-03, 74658-002-04, view more74658-002-05, 74658-002-06, 74658-002-07, 74658-002-08, 74658-002-09, 74658-002-10, 74658-002-11, 74658-002-12, 74658-002-13, 74658-002-14, 74658-002-15 - Packager: GUANGZHOU XUELEI COSMETIC 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 November 4, 2021
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS
- PURPOSE
- USES
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WARNINGS
FOR EXTERNAL USE ONLY. FLAMMABLE. KEEP AWAY FROMFIRE OR FLAME. WHEN USING THIS PRODUCT, AVOID CONTACT WITH EYES. IN CASE OF CONTACT WITH EYES, FLUSH THOROUGHLY WITH WATER. AVOID CONTACT WITH BROKEN SKIN.
STOP USE AND ASK DOCTOR IF IRRITATION OR REDNESS DEVELOPS, OR 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.
- DIRECTIONS
- OTHER INFO
- INACTIVE INGREDIENTS
- KEEP OUT OF REACH OF CHILDREN
- Package Label
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INGREDIENTS AND APPEARANCE
HAND SANITIZER
hand sanitizer gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:74658-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 74 mL in 100 mL Inactive Ingredients Ingredient Name Strength CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31) 0.4 g in 100 mL WATER (UNII: 059QF0KO0R) 23.5 g in 100 mL TROLAMINE (UNII: 9O3K93S3TK) 0.22 g in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:74658-002-02 60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/18/2020 2 NDC:74658-002-01 30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/18/2020 3 NDC:74658-002-03 60 mL in 1 TUBE; Type 0: Not a Combination Product 03/18/2020 4 NDC:74658-002-04 70 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/18/2020 5 NDC:74658-002-05 100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/18/2020 6 NDC:74658-002-06 120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/18/2020 7 NDC:74658-002-07 236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/18/2020 8 NDC:74658-002-08 250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/18/2020 9 NDC:74658-002-09 260 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/18/2020 10 NDC:74658-002-10 290 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/18/2020 11 NDC:74658-002-11 300 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/18/2020 12 NDC:74658-002-12 500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/18/2020 13 NDC:74658-002-13 950 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/18/2020 14 NDC:74658-002-14 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/18/2020 15 NDC:74658-002-15 2000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/18/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 03/18/2020 Labeler - GUANGZHOU XUELEI COSMETIC CO.,LTD. (526885026) Registrant - GUANGZHOU XUELEI COSMETIC CO.,LTD. (526885026) Establishment Name Address ID/FEI Business Operations GUANGZHOU XUELEI COSMETIC CO.,LTD. 526885026 manufacture(74658-002) , pack(74658-002) , label(74658-002)
