Hand Sanitizer: Package Insert and Label Information

HAND SANITIZER- alcohol gel
Sichuan Rejoy Essence Biotechnology 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 62% Purpose Antiseptic

Purpose

Purpose Antiseptic

Uses

Decreases Bacteria On Hands

WARNINGS

For External Use Only

When using this product

When using this product,do not use in or near the eyes.

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.

/

Keep out of reach of children

If swallowed,get medical help or contact a Poison
Control Center immediately.

Directions

Squeeze onto hands and rub hands
together briskly until dry. Do Not Store Above
110°F Non-staining,may discolor certain fabrics

Other information

Do Not Store Above
110°F Non-staining,may discolor certain fabrics

Inactive ingredients

Deionized Water,Carbomer,Triethanolamine,
Aloe Barbadensis ,Ethanol,Glycerol,
Propylene Glycol,Vitamin E.

Package Label — Principal Display Panel

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HAND SANITIZER
hand sanitizer gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:74034-006
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 62 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
PROPYLENE GLYCOL
TRICLOSAN
GLYCERIN
CARBOMER 934
WATER
TROLAMINE
ALOE VERA LEAF
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:74034-006-01 10 mL in 1 BOTTLE None
2 NDC:74034-006-02 20 mL in 1 BOTTLE None
3 NDC:74034-006-03 30 mL in 1 BOTTLE None
4 NDC:74034-006-05 54 mL in 1 BOTTLE None
5 NDC:74034-006-06 100 mL in 1 BOTTLE None
6 NDC:74034-006-08 237 mL in 1 BOTTLE None
7 NDC:74034-006-09 500 mL in 1 BOTTLE None
8 NDC:74034-006-04 50 mL in 1 BOTTLE None
9 NDC:74034-006-07 100 mL in 1 BOTTLE None
10 NDC:74034-006-10 1000 mL in 1 BOTTLE None
11 NDC:74034-006-11 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 04/17/2020
Labeler — Sichuan Rejoy Essence Biotechnology Co., Ltd (407046287)
Establishment
Name Address ID/FEI Operations
Sichuan Rejoy Essence Biotechnology Co., Ltd 407046287 manufacture (74034-006)

Revised: 05/2020 Sichuan Rejoy Essence Biotechnology Co., Ltd

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