Label: PALMIST ANTISEPTIC HAND SANITIZER- ethyl alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 80636-101-01, 80636-101-20, 80636-101-30, 80636-101-40, view more80636-101-45, 80636-101-60 - Packager: POCKET INC
- 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 October 27, 2020
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Warnings
Flammable, keep away from fire/flame
For external use onlyDo not use • in children less than 2 months of age • on open skin wounds
When using this product • do not get into eyes. In case of contact, rinse eyes thoroughly with water
Stop use and ask a doctor if • irritation and redness develop • condition persists for more than 72 hours
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INGREDIENTS AND APPEARANCE
PALMIST ANTISEPTIC HAND SANITIZER
ethyl alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80636-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 70 mL in 100 mL Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) HOLY BASIL LEAF (UNII: SCJ765569P) LEMON OIL (UNII: I9GRO824LL) AZADIRACHTA INDICA LEAF (UNII: HKY915780T) TROLAMINE (UNII: 9O3K93S3TK) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80636-101-01 30 in 1 BOX 09/25/2020 1 1 mL in 1 PACKET; Type 0: Not a Combination Product 2 NDC:80636-101-20 200 in 1 BAG 09/25/2020 2 1 mL in 1 PACKET; Type 0: Not a Combination Product 3 NDC:80636-101-45 30 in 1 BOX 09/25/2020 3 1.5 mL in 1 PACKET; Type 0: Not a Combination Product 4 NDC:80636-101-30 200 in 1 BAG 09/25/2020 4 1.5 mL in 1 PACKET; Type 0: Not a Combination Product 5 NDC:80636-101-60 30 in 1 BOX 09/25/2020 5 2 mL in 1 PACKET; Type 0: Not a Combination Product 6 NDC:80636-101-40 200 in 1 BAG 09/25/2020 6 2 mL in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 09/25/2020 Labeler - POCKET INC (857979919) Establishment Name Address ID/FEI Business Operations POCKET INC 857979919 manufacture(80636-101)