Label: KIDS ANTISEPTIC WIPES- antiseptic wipes alcohol free cloth
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Contains inactivated NDC Code(s)
NDC Code(s): 76523-098-80 - Packager: Valley of the Sun Cosmetics LLC
- 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 13, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor
- Keep out of reach of babies
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Directions
- To dispense, lift cover, remove seal, pull center sheet from roll, twist to a point and feed through dispenser hole in cover. Keep lid closed to prevent moisture loss.
- Open and unfold wipe
- Thoroughly wipe hands, fingers, and wrists. Be sure to use the entire wipe. Allow to dry.
- For dirty hands, use first wipe to clean hands, then discard wipe; sanitize with the second wipe.
- Discard after single use
- Supervise children under 2 years of age when using this product to avoid swallowing
- Other information
- Inactive ingredients
- Package Label
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INGREDIENTS AND APPEARANCE
KIDS ANTISEPTIC WIPES
antiseptic wipes alcohol free clothProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76523-098 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 g in 100 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.3 g in 100 g WATER (UNII: 059QF0KO0R) 97.14 g in 100 g GLYCERIN (UNII: PDC6A3C0OX) 1.45 g in 100 g PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 0.3 g in 100 g PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.15 g in 100 g HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 g in 100 g ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.01 g in 100 g PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG) 0.4 g in 100 g Product Characteristics Color white (White canister with blue cap) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76523-098-80 454 g in 1 CANISTER; Type 0: Not a Combination Product 11/13/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 11/13/2020 Labeler - Valley of the Sun Cosmetics LLC (176470664) Registrant - Valley of the Sun Cosmetics LLC (176470664) Establishment Name Address ID/FEI Business Operations Valley of the Sun Cosmetics LLC 176470664 manufacture(76523-098)