SUN BUM HAND SANITIZER- alcohol liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)

Available from:

Sun Bum LLC

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

to help reduce bacteria on the skin recommended for repeated use

Authorization status:

OTC monograph not final

Summary of Product characteristics

SUN BUM HAND SANITIZER- ALCOHOL LIQUID
SUN BUM LLC
_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._
----------
_DRUG FACTS_
_ACTIVE INGREDIENT_
Ethyl alcohol 62%
_PURPOSE_
Antiseptic
USES
to help reduce bacteria on the skin
recommended for repeated use
_WARNINGS_
FOR EXTERNAL USE ONLY
FLAMMABLE KEEP AWAY FROM FIRE OR FLAME
WHEN USING THIS PRODUCT
do not use in or near the eyes. In case of eye contact, rinse
thoroughly with water.
STOP USE AND ASK A DOCTOR IF
irritation or rash appears and lasts. Condition persists for more than
72 hours
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center
right away.
_DIRECTIONS_
spray enough product in your palms to thoroughly cover your hands
rub hands together briskly until dry
children under 6 years of age should be supervised when using this
product
_OTHER INFORMATION_
do not store above 104° F/40°C
may discolor some fabrics or surfaces
_INACTIVE INGREDIENTS_
water,fragrance,glycerin,aloe barbadensis leaf juice, cucumis sativus
(cucumber) fruit
extract, musa sapientum (banana) fruit extract, hedychium coronarium
root extract,
gardenia taitensis flower extract, cocos nucifera (coconut) oil, sea
salt,
ethylhexylglycerin
_QUESTIONS?_
1-877-978-6286
PACKAGE LABELING:
SUN BUM HAND SANITIZER
alcohol liquid
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:69039-615
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
ALCOHOL
0.62 mL in 1 mL
Sun Bum LLC
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CUCUMBER (UNII: YY7C30VXJT)
BANANA (UNII: 4AJZ4765R9)
HEDYCHIUM CORONARIUM ROOT (UNII: 92A6N0IQN9)
GARDENIA TAITENSIS FLOWER (UNII: T0OCU8201Y)
COCONUT OIL (UNII: Q9L0O73