ISOPROPYL ALCOHOL by Point One International, Ltd. / Kangna (Zhejiang) Medical Supplies Co., Ltd. RPPE Bamboo Wipes

ISOPROPYL ALCOHOL by

Drug Labeling and Warnings

ISOPROPYL ALCOHOL by is a Otc medication manufactured, distributed, or labeled by Point One International, Ltd., Kangna (Zhejiang) Medical Supplies Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ISOPROPYL ALCOHOL- hand wipes cloth 
Point One International, 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.

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RPPE Bamboo Wipes

Active Ingredient

lsopropyl Alcohol (70% by volume)

Purpose

Antimicrobial

Sanitizer to help reduce bacteria on hands

Warning

Flammable, keep away from fire or flame.

When using this product - Keep out of eyes - ln case of contact with eyes, flush thoroughly with water - Avoid contact with broken skin.

Do not store above 104°F/40°C.

Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.

keep out of reach of children. If swallowed, contact medical help or call Poison Control immediately

For external use only

Directions

For use apply thoroughly to hands as desired. Allow to dry without
wiping. Discard wipe in trash receptacle after use. Do not flush.
For dispensing peel back front label at tab. Remove towelettes as needed. Reseal pouch by pressing label firmly back into place.

Inactive ingredients

Water, Aloe vera extract

Label

ISOPROPYL ALCOHOL 
hand wipes cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81207-012
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81207-012-01	10 mL in 1 BAG; Type 0: Not a Combination Product	12/31/2020	12/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	12/31/2020	12/31/2020

Labeler - Point One International, Ltd. (150340206)

Establishment
Name	Address	ID/FEI	Business Operations
Point One International, Ltd.		150340206	pack(81207-012) , label(81207-012)

Establishment
Name	Address	ID/FEI	Business Operations
Kangna (Zhejiang) Medical Supplies Co., Ltd.		554530173	manufacture(81207-012)

Revised: 7/2022

Document Id: e34cd94e-4133-832f-e053-2a95a90aaa86

34390-5

Set id: bdad5c3b-2e6f-2872-e053-2a95a90a659c

Version: 2

Effective Time: 20220708