FDA.reportPublic FDA data

zero bumps bikini spray

Manufacturer
Coty US LLC
Effective date
2021-10-19
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
full-release
Hydrated at
2026-05-31 23:44:19

Label at a glance#

ProductSally Hansen Zero bump bikini
Active ingredientPRAMOXINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

For temporary relief of pain and itching associated with minor cuts or minor skin irritation due to hair removal.

Dosage and administration

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.

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active IngredientPurpose
Pamoxine Hcl 1%Topical Analgesic

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Stop use and ask a doctor if

OTC - ASK DOCTOR SECTION

  • Condition gets worse
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again with a few days

Warnings

WARNINGS SECTION

  • ​For external use only
  • When using this product avoid contact with the eyes

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a poison control center right away.

Directions

OTHER SAFETY INFORMATION

  • 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

INACTIVE INGREDIENT SECTION

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

INDICATIONS & USAGE SECTION

For temporary relief of pain and itching associated with minor cuts or minor skin irritation due to hair removal.

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

coty 2coty 2coty 1coty 1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1294036pramoxine HCl 1 % Topical SprayPSN12
1294036pramoxine hydrochloride 10 MG/ML Topical SpraySCD12
1294036pramoxine hydrochloride 1 % Topical SpraySY12

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66184-160-022023-01-30C16284748780-1f386c64a-443e-0266-e053-dadaa90a7c1azero bumps bikini spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66184-160-01Sally Hansen Zero bump bikini25 mL in 1 BOTTLE, SPRAYSPRAY2512
66184-160-02Sally Hansen Zero bump bikini1 in 1 BLISTER PACKSPRAY112

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66184-160SALLY HANSEN ZERO BUMP BIKINI (PRAMOXINE HYDROCHLORIDE) SPRAY [COTY US LLC]12Legacy NDC, 2 package rows20211020_33342f93-728c-0fd8-e054-00144ff88e88.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66184-16066184-160-01, 66184-160-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Name, UNII, Kind table
NameUNIIKind
HAMAMELIS VIRGINIANA FLOWER WATER222MYC9QUVIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
EDETATE SODIUM TETRAHYDRATEL13NHD21X6IACT
BENZYL BENZOATEN863NB338GIACT
CITRUS AURANTIUM FLOWERO730ZX2Z83IACT
ALOE VERA LEAFZY81Z83H0XIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ORCHIS MASCULA FLOWER6H1JQK35LAIACT
PASSIFLORA INCARNATA FLOWERK8F3G29S6ZIACT
SODIUM HYDROXIDE55X04QC32IIACT
N-(3,4-BIS(HYDROXYMETHYL)-2,5-DIOXO-4-IMIDAZOLIDINYL)-N,N'-BIS(HYDROXYMETHYL)UREA483JN0JNJAIACT
ISOBUTYLPARABEN0QQJ25X58GIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
PHENOXYETHANOLHIE492ZZ3TIACT
LACTIC ACID, DL-3B8D35Y7S4IACT
PEG-12 DIMETHICONE (300 CST)ZEL54N6W95IACT
SOYBEAN OIL241ATL177AIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
.BETA.-TOCOPHEROL9U6A490501IACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
PROPYLPARABENZ8IX2SC1OHIACT
BUTYLPARABEN3QPI1U3FV8IACT
ETHYLPARABEN14255EXE39IACT
CITRIC ACID ACETATEDSO12WL7AUIACT
PRAMOXINE HYDROCHLORIDE88AYB867L5ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ceb50c62-f348-a4e2-e053-2995a90acd3c33342f93-728c-0fd8-e054-00144ff88e882021-10-19WarningsExact identifier
spl id: ceb50c62-f348-a4e2-e053-2995a90acd3c
spl set id: 33342f93-728c-0fd8-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.