Not Have: Package Insert and Label Information

NOT HAVE- alcohol gel
Guangzhou Yucaitang Cosmetics 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

ALCOHOL 73.0%

Purpose

Antimicrobial

Uses

Hand Sanitizer to help reduce bacteria on skin.

WARNINGS

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

When using this product

do not use in or near the eyes.In case of contact,rinse eyes thoroughly with water.Stop use and ask doctor if irritation or rash appears and lasts.Keep out of reach for children.If swallowed,get medical help or contact a Poison Control Center right away.

Directions

Place enough Product in your palm to thoroughly spread on both hands and rub into the skin until dry.

Children under 6 years of age should be supervised when using this product.

Other Information

Store below 106°F.(4I°C)

May discolor certain fabrics or surfaces.

INACTIVE INGREDIENTS

WATER.GLYCERIN.CARBOMER.TRIETHANOLAMINE.

Package Label — Principal Display Panel

5 ml label
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50 ml label
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60 ml label
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100 ml label
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200 ml label
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300 ml label
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500 ml label
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1 L label
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NOT HAVE
hand sanitizer gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:75439-001
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 73 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
WATER
TROLAMINE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:75439-001-01 5 mL in 1 BAG None
2 NDC:75439-001-02 50 mL in 1 AMPULE None
3 NDC:75439-001-03 60 mL in 1 BOTTLE None
4 NDC:75439-001-04 100 mL in 1 BOTTLE None
5 NDC:75439-001-05 200 mL in 1 BOTTLE None
6 NDC:75439-001-06 300 mL in 1 BOTTLE None
7 NDC:75439-001-07 500 mL in 1 BOTTLE None
8 NDC:75439-001-08 1000 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 05/05/2020
Labeler — Guangzhou Yucaitang Cosmetics Co., Ltd. (526897391)
Registrant — Guangzhou Yucaitang Cosmetics Co., Ltd. (526897391)
Establishment
Name Address ID/FEI Operations
Guangzhou Yucaitang Cosmetics Co., Ltd. 526897391 manufacture (75439-001)

Revised: 04/2020 Guangzhou Yucaitang Cosmetics Co., Ltd.

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