OTC Medication Information: Hand Sanitizer

HAND SANITIZER- alcohol gel
Skaffles Group Limited Liability Company

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.

Active Ingredient

Ethyl Alcohol 71%

Purpose

Antiseptic

USE

Hand sanitizing to help reduce bacteria on the skin. Recommended for repeated use.

Warning

For external use only. Flammable. Keep away from fire or flame. When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.
Discontinue use if irritation and redness develop. lf condition persists for more than 72 hours consult a physician.

Keep out of reach of children. If swallowed, get medical
help or contact a Poison Control Center right away.

Directions

Squeeze gel into your palm and briskly rub hands together until dry.
Children under 6 years of age should be supervised when in use.
Other information . Store between 15 and 30C (59 and86F).·Avoid freezing and excessive heat above 40C(104F).

Inactive ingredients

Aloe Barbadensis Leaf Extract, Carbomer,Glycerin,Tocopheryl Acetate (Vitamin E), Triethanolamine, Water(Aqua).

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HAND SANITIZER
ethyl alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:77720-017
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 71 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
ALOE VERA LEAF
WATER
TROLAMINE
ALPHA-TOCOPHEROL ACETATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:77720-017-01 100 BAG in 1 CARTON contains a BAG
1 2 mL in 1 BAG This package is contained within the CARTON (77720-017-01)
2 NDC:77720-017-02 50 BAG in 1 CARTON contains a BAG
2 2 mL in 1 BAG This package is contained within the CARTON (77720-017-02)
3 NDC:77720-017-03 200 BAG in 1 CARTON contains a BAG
3 2 mL in 1 BAG This package is contained within the CARTON (77720-017-03)
4 NDC:77720-017-04 300 BAG in 1 CARTON contains a BAG
4 2 mL in 1 BAG This package is contained within the CARTON (77720-017-04)
5 NDC:77720-017-05 500 BAG in 1 CARTON contains a BAG
5 2 mL in 1 BAG This package is contained within the CARTON (77720-017-05)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 12/30/2020
Labeler — Skaffles Group Limited Liability Company (831115642)
Establishment
Name Address ID/FEI Operations
Shenzhen Lantern Science Co.,Ltd 421222423 manufacture (77720-017)

Revised: 01/2021 Skaffles Group Limited Liability Company

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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