Label: VAMOUSSE PRO LICE TREATMENT- sodium chloride liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 58962-010-01 - Packager: Tyra Tech, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated September 29, 2015
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- Uses
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Warnings
For external use only
Do not use
- near eyes
- inside nose
- mouth
- vagina
- eyebrows or eyelashes.
See a doctor if lice are present in these areas.
When using this product:
- Keep eyes tightly closed and protect eyes with a washcloth or towel.
- If product gets in eyes, flush with water right away.
- Scalp itching or redness may occur.
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Directions
Adults and children 2 years and older.
- Separate hair into sections, working with 1 inch sections at a time following your normal combing procedure.
- Thoroughly saturate all hair and scalp as you work, massaging product into the hair generously. To be effective, all lice and nits must come in contact with the product. Note: dilution may reduce efficacy.
- Use approximately 2 fl oz (2 – 3 pumps) of lotion for an average head of hair.
- If product needs to be thinned for particular hair type, use a spray bottle to lightly spritz the hair with water, allowing lotion to spread more easily.
- Using a lice/nit comb, comb hair from as close to the scalp as possible to the end of the hair.
- If hair dries during combing, apply more product or use a spray bottle to lightly spritz the hair with water, rehydrating the lotion.
- After combing, thoroughly recheck for lice/nits. Repeat combing if necessary.
Product may be used as often as needed. Children under 2 years old: ask a doctor.
- Other Information
- Inactive Ingredients
- Questions?
- PRINCIPAL DISPLAY PANEL - 946 ML Bottle Label
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INGREDIENTS AND APPEARANCE
VAMOUSSE PRO LICE TREATMENT
sodium chloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58962-010 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698, SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE 2 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL (UNII: LKG8494WBH) BUTYL LACTATE (UNII: 0UI63W814U) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP) DMDM HYDANTOIN (UNII: BYR0546TOW) GERANIOL (UNII: L837108USY) ISOPROPYL ALCOHOL (UNII: ND2M416302) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) MAGNESIUM NITRATE (UNII: 77CBG3UN78) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) PEPPERMINT OIL (UNII: AV092KU4JH) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58962-010-01 946 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED HOMEOPATHIC 09/25/2015 Labeler - Tyra Tech, Inc. (782845882) Establishment Name Address ID/FEI Business Operations Tropical Products, Inc. 157469086 MANUFACTURE(58962-010) , LABEL(58962-010)
