OTC Medication Information: INSTANT HAND SANITIZER

INSTANT HAND SANITIZER- alcohol gel
ShangRao chunyu Technology CO.,LTD.

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(s)

Ethyl Alcohol 70%

Purpose

Antiseptic

Use

Helps reduce bacteria on skin. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from fire or flame.

Do not use

do not use in or near tile eyes

When using this product do not use in or near tile eyes. In case of contact, rinse eyes thoroughly with water. Do not use on open skin wounds. Stop use and ask a doctor if irritation or rash appears and lasts. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if irritation or rash appears and lasts.

Keep out of reach of children.

Directions

Apply enough product on hands to cover all surfaces. Rub hands together until dry.
Supervise children under 6 years of age when using this product.

Other information

Do not store in temperature over 118°F.

Inactive ingredients

Water, Carbomer, Triethanolamine, Fragrance, May contain: Red 4 (Cl 14700), Red 33 (Cl 17200), Ext. Violet 2 (Cl160730), Blue 1 (Cl 142090), Yellow 5 (Cl 19140), Glycerine, Tocopherol (Vitamin E), Aloe Barbadensis Leaf Juice.

Package Label — Principal Display Panel

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INSTANT HAND SANITIZER
instant hand sanitizer gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:72922-054
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 70 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
TROLAMINE
WATER
FRAGRANCE LAVENDER & CHIA F-153480
D&C RED NO. 33
EXT. D&C VIOLET NO. 2
GLYCERIN
ALOE VERA LEAF
PODOPHYLLUM RESIN
TOCOPHEROL
FD&C BLUE NO. 1
FD&C YELLOW NO. 5
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72922-054-01 59 mL in 1 BOTTLE None
2 NDC:72922-054-02 60 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 03/30/2020
Labeler — ShangRao chunyu Technology CO.,LTD. (541569308)
Establishment
Name Address ID/FEI Operations
JEAN PIERRE INC. 138328393 label (72922-054)
Establishment
Name Address ID/FEI Operations
ShangRao chunyu Technology CO.,LTD. 541569308 manufacture (72922-054)

Revised: 04/2021 ShangRao chunyu Technology CO.,LTD.

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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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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