SANIMAX- alcohol cloth
SYNDICATE ONE GROUP 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.

----------

Active Ingredient

Ethyl Alcohol 75% v/v.

Purpose

Antiseptic

Use

decreases bacteria on skin.

Warnings

For external use only.

Flammable. Keep away from heat and flame.

When using the product

keep out of eyes, in case of contact with eyes, flush thoroughly with water
avoid contact with broken skin
do not inhale or ingest
do not reuse wipe
do not flush in toilet

Stop use and ask a doctor if skin irritation develops.

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

Directions

Wipe down surface thoroughly and allow to air-dry.
For children under 6, use only under adult supervision
Not recommended for infants

Other information

do not store above 105°F

Inactive ingredients

purified water, glycerin. aloe barbadensis extract, phenoxyethanol, ethylhexlyglycerin, propylene glycol

Product Labels

image description

SANIMAX
alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:79308-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:79308-001-01	80 in 1 CANISTER	05/22/2020
1		4.3 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
2	NDC:79308-001-02	80 in 1 CANISTER	05/22/2020
2		4.3 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
3	NDC:79308-001-03	80 in 1 CANISTER	05/22/2020
3		4.3 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	05/22/2020

Labeler - SYNDICATE ONE GROUP INC (117555403)