BOTANIKA LIFE ULTRA-RELIEF PAIN RUB- lidocaine, menthol oil

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987), MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)

Available from:

Prime Enterprises, Inc.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Topical Analgesic For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites or minor skin irritations.

Authorization status:

OTC monograph not final

Summary of Product characteristics

BOTANIKA LIFE ULTRA-RELIEF PAIN RUB- LIDOCAINE, MENTHOL OIL
PRIME ENTERPRISES, 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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BOTANIKA LIFE ULTRA-RELIEF PAIN RUB
_ACTIVE INGREDIENTS_
Lidocaine 4%
Menthol 1%
_PURPOSE_
Topical Analgesic
_USES_
For the temporary relief of pain and itching associated with minor
burns, sunburn, minor
cuts, scrapes, insect bites or minor skin irritations.
_WARNINGS_
FOR EXTERNAL USE ONLY
DO NOT USE
in large quantities, particularly over raw surfaces or blistered
areas.
WHEN USING THIS PRODUCT
avoid contact with the eyes.
Use only as directed.
STOP USE AND ASK A DOCTOR IF
condition worsens, or if symptoms persist for more than 7 days or
clear up and occur
again within a few days.
KEEP OUT OF REACH OF CHILDREN.
If product is swallowed, get medical help or contact a Posion Control
Center right away.
IF PREGNANT OR BREAST-FEEDING,
ask a health professional before use.
_DIRECTIONS_
ADULTS AND CHILDREN 2 YEARS OF AGE AND OLDER:
Apply to affected area not more than 3 to 4 times daily
Children under 2 years of age: Consult a doctor.
_INACTIVE INGREDIENTS_
Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract,
Butyrospermum Parkii
(Shea) Butter, Cannabidiol, Coconut Oil, Cocos Nucifera (Coconut) Oil,
Euphorbia
Cerifera (Candelilla) Wax, Olea Europaea (Olive) Fruit Oil, Prunus
Amygdalus Dulcis
(Sweet Almond) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Tocopheryl
Acetate
BOTANIKA LIFE ULTRA-REPAIR PAIN RUB
BOTANIKA LIFE ULTRA-RELIEF PAIN RUB
lidocaine, menthol oil
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:58443-0392
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)
LIDOCAINE
34.24 mg in 1 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)
MENTHOL
8.56 mg in 1 mL
I