Hand Sanitizer Lemon 2oz: Package Insert and Label Information

HAND SANITIZER LEMON 2OZ- alcohol liquid
China Ningbo Shangge 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.

Ethyl Alcohol 70% v/v.

Purpose

Antimicrobial

Use

  • for handwashing to decrease bacteria on the skin
  • recommended for repeated use

Warnings

For external use only. Flammable, keep away from heat or flame

Do not use

  • in the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rednees develp and persist for more than 72 hours.

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

Directions

  • Wet hands thoroughly with product
  • briskly rub hands together until dry.
  • Supervise children under 6 years of age when using this product.

Other information

  • Store at room temperature
  • may discolor certain fabrics

Inactive ingredients

water, carbomer, triethanolamine, glycerin, propylene glycol, fragrance, aloe barbadensis leaf juice, tocopheryl acetate, fd&c yellow no.5.

1-855-345-5575

Package Label — Principal Display Panel

label 2
(click image for full-size original)

HAND SANITIZER LEMON 2OZ
alcohol liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:58503-159
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
WATER
TROLAMINE
PROPYLENE GLYCOL
GLYCERIN
ALOE
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
ALPHA-TOCOPHEROL ACETATE
FD&C YELLOW NO. 5
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58503-159-01 59 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 09/28/2020
Labeler — China Ningbo Shangge Technology Co., Ltd. (529287434)
Establishment
Name Address ID/FEI Operations
China Ningbo Shangge Technology Co., Ltd. 529287434 manufacture (58503-159)

Revised: 10/2020 China Ningbo Shangge Technology Co., Ltd.

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