SALLY HANSEN ZERO BUMP BIKINI- pramoxine hydrochloride spray

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)

Available from:

Coty US LLC

INN (International Name):

PRAMOXINE HYDROCHLORIDE

Composition:

PRAMOXINE HYDROCHLORIDE 10 mg in 1 mL

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Topical Analgesic - Condition gets worse - symptoms persist for more than 7 days - symptoms clear up and occur again with a few days For temporary relief of pain and itching associated with minor cuts or minor skin irritation due to hair removal.

Authorization status:

OTC monograph not final

Summary of Product characteristics

SALLY HANSEN ZERO BUMP BIKINI- PRAMOXINE HYDROCHLORIDE SPRAY
COTY US 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._
----------
ZERO BUMPS BIKINI SPRAY
DRUG FACTS
Active Ingredient
Purpose
Pamoxine Hcl 1%
Topical Analgesic
PURPOSE
Topical Analgesic
STOP USE AND ASK A DOCTOR IF
Condition gets worse
symptoms persist for more than 7 days
symptoms clear up and occur again with a few days
WARNINGS
​For external use only
When using this product avoid contact with the eyes
KEEP OUT OF REACH OF CHILDREN
If swallowed, get medical help or contact a poison control center
right away.
DIRECTIONS
Adults and children 2 years of age and older apply product to affected
area not more
than 3 to 4 times daily.
Children under 2 years of age consult a doctor
Use after shaving, waxing or after using hair removal creams. Will not
stain lingerie,
swimwear or clothing.
INACTIVE INGREDIENTS
AQUA/WATER/EAU, HAMAMELIS VIRGINIANA (WITCH HAZEL) WATER,
ALCOHOL, GLYCERIN, BUTYLENE GLYCOL, SODIUM CITRATE, PHENOXYETHANOL,
LACTIC ACID,
PARFUM/FRAGRANCE, PEG-12 DIMETHICONE, ETHYLHEXYLGLYCERIN, TETRASODIUM
EDTA, BENZYL
BENZOATE, PROPYLENE GLYCOL, CITRUS AURANTIUM DULCIS (ORANGE) FLOWER
EXTRACT, ORCHIS
MASCULA FLOWER EXTRACT, PASSIFLORA INCARNATA EXTRACT, ALOE BARBADENSIS
LEAF EXTRACT,
SODIUM HYDROXIDE, GLYCINE SOJA (SOYBEAN) SEED EXTRACT, TOCOPHEROL,
IMIDAZOLIDINYL UREA,
METHYLPARABEN, DIAZOLIDINYL UREA, PROPYLPARABEN, BUTYLPARABEN,
ETHYLPARABEN,
ISOBUTYLPARABEN, CITRIC ACID
USES
For temporary relief of pain and itching associated with minor cuts or
minor skin
irritation due to hair removal.
LABEL
SALLY HANSEN ZERO BUMP BIKINI
pramoxine hydrochloride spray
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:66184-160
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (P