Label: ADVANCED 2 IN 1 HAND SANITIZER- alcohol gel
- NDC Code(s): 74923-100-01
- Packager: THE SUN 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.
Updated June 4, 2020
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- ACTIVE INGREDIENT
- INACTIVE INGREDIENTS
For external use only. Flammable. Keep away from heat and flame.
Do not use ■ In children less than 2 months of age. ■ On open skin wounds
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
■ Place enough product on hands to cover all surfaces. Rub hands together until dry.
■ For children under 6, use only under adult supervision
■ Avoid direct inhalation of vapors during application (Headaches and irritation to mucous membranes may occur when directly inhaled.)
■ This product is intended only for hand sanitizing.
■ To prevent drying out and contamination, close the lid completely after use.
■ Keep in their original container not to cause accidents nor diminish the integrity of the product.
■ Do not use over bandages, castings, etc. ad irritation may occur.
- Other Information
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
ADVANCED 2 IN 1 HAND SANITIZER
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:74923-100 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Alcohol (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) Alcohol 350 mL in 500 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) AminomethylPropanol (UNII: LU49E6626Q) ALOE VERA LEAF (UNII: ZY81Z83H0X) CITRUS PARADISI SEED (UNII: 12F08874Y7) GREEN TEA LEAF (UNII: W2ZU1RY8B0) Butylene Glycol (UNII: 3XUS85K0RA) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) Phenoxyethanol (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:74923-100-01 500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 05/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 05/01/2020 Labeler - THE SUN CO.LTD (694433104) Registrant - THE SUN CO.LTD (694433104) Establishment Name Address ID/FEI Business Operations THE SUN CO.LTD 694433104 manufacture(74923-100)