Label: YANKEE CANDLE HAND SANITIZER WITH MOISTURIZER PINK SANDS- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 80123-001-01, 80123-001-02, 80123-001-03, 80123-001-04 - Packager: THE YANKEE CANDLE COMPANY 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 August 31, 2020
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- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
- Use
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Warnings
For external use only.
Flammable, keep away from fire, flame or sparks.
Do not use on damaged or broken skin | in or near eyes, ears or mouth | on children less than 2 months of age.
- Directions
- Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 118.3 ML Bottle Label
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INGREDIENTS AND APPEARANCE
YANKEE CANDLE HAND SANITIZER WITH MOISTURIZER PINK SANDS
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80123-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol 62.5 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALOE VERA LEAF (UNII: ZY81Z83H0X) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) DENATONIUM BENZOATE (UNII: 4YK5Z54AT2) TERT-BUTYL ALCOHOL (UNII: MD83SFE959) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) DIMETHICONE PEG-7 ISOSTEARATE (UNII: JVS3399FNW) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80123-001-01 118.3 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/26/2020 2 NDC:80123-001-02 3 in 1 PACKAGE 10/26/2020 2 118.3 mL in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:80123-001-03 236.6 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/26/2020 4 NDC:80123-001-04 2 in 1 PACKAGE 10/26/2020 4 236.6 mL in 1 BOTTLE; 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 10/26/2020 Labeler - THE YANKEE CANDLE COMPANY INC (066983586) Establishment Name Address ID/FEI Business Operations Tri-Pac, Inc. 020844956 MANUFACTURE(80123-001)