DOUGLAS - HAND SANITIZER 75 PERCENT- isopropyl alcohol gel
Douglas Pads & Sports, 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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Douglas

ACTIVE INGREDIENT

ISOPROPYL ALCOHOL 75%

PURPOSE

ANTISEPTIC

USES

HEALTH CARE PERSONNEL HAND RUB TO HELP REDUCE BACTERIA THAT POTENTIALLY CAN CAUSE DISEASE.

WARNINGS

FOR EXTERNAL USE ONLY.

FLAMMABLE, KEEP AWAY FROM HEAT OR FLAME.

DO NOT USE

IN CHILDREN LESS THAN 2 MONTHS OF AGE
ON OPEN SKIN WOUNDS

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.

DIRECTIONS

PLACE ENOUGH PRODUCT ON HANDS TO COVER ALL SURFACES. RUB HANDS TOGETHER UNTIL DRY.
SUPERVISE CHILDREN UNDER 6 YEARS OF AGE WHEN USING THIS PRODUCT TO AVOID SWALLOWING.

OTHER INFORMATION

STORE BETWEEN 15-30°C (58-86°F)
AVOID FREEZING AND EXCESSIVE HEAT ABOVE 40°C (104°F)

INACTIVE INGREDIENTS

DI WATER, CARBOPOL, PROPYLENE GLYCOL, TEA, FRAGRANCE, POLYSORBATE 20

01b LBL_2020 Douglas-Hand-Sanitizer-Label-fnl

DOUGLAS - HAND SANITIZER 75 PERCENT
isopropyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:78510-101
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	75 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TROLAMINE (UNII: 9O3K93S3TK)
POLYSORBATE 20 (UNII: 7T1F30V5YH)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:78510-101-12	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/02/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	06/02/2020

Labeler - Douglas Pads & Sports, Inc (161798285)