Hand Sanitizer Pump Blooming Peony

Hand Sanitizer Pump Blooming Peony by

Drug Labeling and Warnings

Hand Sanitizer Pump Blooming Peony by is a Otc medication manufactured, distributed, or labeled by BASE4 Ventures, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER PUMP BLOOMING PEONY- alcohol gel 
BASE4 Ventures, Inc

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.

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Hand Sanitizer Pump Blooming Peony

Drug Facts

Active Ingredient

Alcohol Denat. 66% (V/V)

Purpose

Antiseptic

Uses

• hand sanitizer to help decrease bacteria on the skin.
• recommended for repeated use.

Warnings

• For external use only.
• Flammable. 
• Keep away from heat or flame. 
• Does not contain grain alcohol; do not drink. If taken internally will produce severe gastric disturbances.

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 a doctor

if redness or irritation develop and lasts.

Keep out of reach of children.

If swallowed, get medical help or contact a poison control center immediately.

Directions

• Rub dime sized amount between hands until dry.
• Supervise children in the use of this product. In the case of eye contact rinse eyes thoroughly with water

Other information

• Do not store above 105°F.
• May discolor some fabrics.

Inactive ingredients

Acrylates/C10-30 alkyl acrylates crosspolymer, Aminomethyl propanol, D&C Red No.33, Disodium EDTA, FD&C Blue No.1, FD&C Red No.4, FD&C Yellow No.5, Fragrance, Water

Package Labeling:

HAND SANITIZER PUMP BLOOMING PEONY 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62651-045
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.66 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
WATER (UNII: 059QF0KO0R)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62651-045-01	236.5 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/04/2020	12/04/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	12/04/2020	12/04/2021

Labeler - BASE4 Ventures, Inc (137316126)

Revised: 5/2021

Document Id: c182bdc2-b676-c4c0-e053-2995a90a39fb

34390-5

Set id: b48d14f2-9432-6bf7-e053-2a95a90a01af

Version: 2

Effective Time: 20210504