Label: AIR AND WATER HAND SANITIZER - MERRY PEPPERMINT- ethyl alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 69933-400-50, 69933-400-60 - Packager: Pearl World 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 September 17, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Purpose
- Uses
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Warnings
For external use only: hands.
Flammable. Keep away from fire or flame.
When using this product • Keep out of eyes, ears, or mouth. • In case of eye contact, flush eyes thoroughly with water. • Avoid contact with broken skin. • Do not inhale or ingest.
Stop use and ask a doctor if • Redness or irritation develop • Condition persists for more than 72 hours.
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
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INACTIVE INGREDIENT
Inactive ingredients: Water (Aqua), Triethanolamine, Carbomer, Aloe Barbadensis Leaf Extract, Fragrance, Glycerin, Propylene Glycol, Tocopheryl Acetate (Vitamin E). Main Contain: FD & C Red 40 (CI 16035), FD & C Yellow 6 (CI 15985), FD & C Violet 2 (CI 60725), FD & C Blue 1 (CI 42090), FD & C Yellow 5 (CI 19140), FD & C Red 33(CI 17200).
- SPL UNCLASSIFIED SECTION
- Packaging
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INGREDIENTS AND APPEARANCE
AIR AND WATER HAND SANITIZER - MERRY PEPPERMINT
ethyl alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69933-400 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 WATER (UNII: 059QF0KO0R) TROLAMINE (UNII: 9O3K93S3TK) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) ALOE VERA LEAF (UNII: ZY81Z83H0X) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) D&C VIOLET NO. 2 (UNII: 350KA7O6HK) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 33 (UNII: 9DBA0SBB0L) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69933-400-50 500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 09/17/2020 2 NDC:69933-400-60 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/17/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 09/17/2020 Labeler - Pearl World Inc. (043130142)