Label: SURGICAL AND HEALTHCARE PERSONNEL HAND ANTISEPTIC WITH MOISTURIZERS- alcohol liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 79996-700-01, 79996-700-02, 79996-700-03, 79996-700-04, view more79996-700-05, 79996-700-06 - Packager: EPOXEMEX, S.A. DE C.V.
- 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 June 30, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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SPL UNCLASSIFIED SECTION
This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.
The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:
- Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (70%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
- Chlorhexidine Gluconate (1%, volume/weight (v/w) )
- Aloe Barbadensis Leaf Extract
- Fragance
- Glycerin
- Polyethylene Glycol
- Sterile distilled water or boiled cold water.
The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.
- Active Ingredient(s)
- Purpose
- Use
- Warnings
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Do not use
- If you are allergic to chlorhexidine gluconate or any other ingredient in this preparation.
- When using this product:
- Do not touch eyes with hands that have been treated with this preparation.
- Keep out of eyes, ears and mouth.
- May caus srious and permanent eye injure if prmitted to enter and remain in eyes
- If contact occurs, rinse with cold water right away
- Do not use routenely if you have wounds which involve more than the superficial layers of the skin
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WHEN USING
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. If swallowed, get medical help or contact a Poison Control Center right away. - STOP USE
- KEEP OUT OF REACH OF CHILDREN
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Directions
- Use with care in premature infants or infants undr 2 months of age. These products may cause irritation or chemical burns.
- Surgical hand antiseptic apply to clean, dry hands and nails. For the first use of each day, clean under nails with a nail stick, dispense one pump (2 ml) into the palm of one hand, dip the fingertips of the opposite hand into the lotion and work it under the nails, spread the remaining lotion over the hand and up to just above the elbow, using another 2 ml of lotion, repeat with the other hand, dispnese another 2 ml of lotion into the other hand, reapply thoroughly to both hands up to the wrists. Allow to dry before donning gloves.
- Healthcare personnel hand antiseptic apply to clean, dry hands and nails, dispense one pump (2 ml) into the palm of one hand, paying particular attention to the spaces between the fingers and under fingernails, apply the product evenly to cover both hands up to the wrists, allow to dry without wiping.
- Other information
- Inactive ingredients
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
SURGICAL AND HEALTHCARE PERSONNEL HAND ANTISEPTIC WITH MOISTURIZERS
alcohol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79996-700 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE 1 g in 100 mL ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 70 mL in 100 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) ALOE VERA LEAF (UNII: ZY81Z83H0X) WATER (UNII: 059QF0KO0R) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79996-700-01 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/30/2020 12/31/2021 2 NDC:79996-700-02 4000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/30/2020 12/31/2021 3 NDC:79996-700-03 20000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/30/2020 12/31/2021 4 NDC:79996-700-04 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/30/2021 5 NDC:79996-700-05 4000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/30/2021 6 NDC:79996-700-06 20000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/30/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 03/30/2020 Labeler - EPOXEMEX, S.A. DE C.V. (814573127) Registrant - AY CONSULTING SERVICES, LLC (078311971) Establishment Name Address ID/FEI Business Operations EPOXEMEX, S.A. DE C.V. 814573127 manufacture(79996-700)
