LACTOVIT DEODORANT ANTIPERSPIRANT LACTOUREA- aluminum chlorohydrate cream AC MARCA PERSONAL CARE, S.L. 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. ------Lactovit Deodorant Antiperspirant Lactourea

Drug Facts

Active ingredient Aluminum chlorohydrate 10%

Purpose Antiperspirant

Uses Reduces underarm wetness.

Warning For external use only.

Do not use on broken skin. In case of accidental ingestion seek Professional Assistance or contact a Poison Control Center immediately. Keep away from face and mouth.

Ask a Doctor or pharmacists before use if you have kidney disease.

Stop use and ask a doctor if rash or irritation occurs.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions Apply to underarms only.

Other information: Store at room temperature.

Inactive ingredients water, steareth-2, PPG-15 stearyl ether, steareth-21,fragrance, butylene glycol, xanthan gum, hydrolyzed milk protein, calcium lactate, sodium lactate, tocopheryl acetate, tocopherol, niacinamide, allantoin, hydroxyethyl urea, propanediol, bisabolol, farnesol, lecithin, glycine, polyglyceryl-3 caprylate, cyclopentasiloxane, helianthus annus (sunflower) seed oil, disodium EDTA, VP/eicosene copolymer, phenoxyethanol, alpha isomethyl ionone, citral, citronellol, coumarin, limonene, geraniol, hexyl cinnamal, butylphenyl methylpropional, linalool,hydroxycitronellal.

Questions or comments: + 1-787-780-4043

Package Labeling:

LACTOVIT DEODORANT ANTIPERSPIRANT LACTOUREA aluminum chlorohydrate cream

Product Information Product T ype HUMAN OTC DRUG Ite m Code (Source ) NDC:4228 3-0 45 Route of Administration TOPICAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALUMINUM CHLO RO HYDRATE (UNII: HPN8 MZW13M) (ALUMINUM CHLOROHYDRATE - ALUMINUM 10 0 mg UNII:HPN8 MZW13M) CHLOROHYDRATE in 1 mL

Inactive Ingredients Ingredient Name Strength WATER (UNII: 0 59 QF0 KO0 R) STEARETH-2 (UNII: V56 DFE46 J5) PPG-15 STEARYL ETHER (UNII: 1II18 XLS1L) STEARETH-2 1 (UNII: 53J3F32P58 ) BUTYLENE GLYCO L (UNII: 3XUS8 5K0 RA) XANTHAN GUM (UNII: TTV12P4NEE) CALCIUM LACTATE (UNII: 2URQ2N32W3) SO DIUM LACTATE (UNII: TU7HW0 W0 QT) .ALPHA.-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 ) TO CO PHERO L (UNII: R0 ZB2556 P8 ) NIACINAMIDE (UNII: 25X51I8 RD4) ALLANTO IN (UNII: 344S277G0 Z) HYDRO XYETHYL UREA (UNII: MBQ7DDQ7AR) PRO PANEDIO L (UNII: 59 6 5N8 W8 5T) LEVO MENO L (UNII: 24WE0 3BX2T) FARNESO L (UNII: EB41QIU6 JL) GLYCINE (UNII: TE76 6 0 XO1C) CYCLO METHICO NE 5 (UNII: 0 THT5PCI0 R) SUNFLO WER O IL (UNII: 3W1JG79 5YI) EDETATE DISO DIUM ANHYDRO US (UNII: 8 NLQ36 F6 MM) PHENO XYETHANO L (UNII: HIE49 2ZZ3T) ISO METHYL-.ALPHA.-IO NO NE (UNII: 9 XP4LC555B) CITRAL (UNII: T7EU0 O9 VPP) .BETA.-CITRO NELLO L, (R)- (UNII: P0 1OUT9 6 4K) CO UMARIN (UNII: A4VZ22K1WT) LIMO NENE, (+)- (UNII: GFD7C8 6 Q1W) GERANIO L (UNII: L8 3710 8 USY) .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6 O37OK2I) BUTYLPHENYL METHYLPRO PIO NAL (UNII: T7540 GJV6 9 ) LINALO O L, (+/-)- (UNII: D8 1QY6 I8 8 E) HYDRO XYCITRO NELLAL (UNII: 8 SQ0 VA4YUR)

Packaging Marketing Start Marketing End # Item Code Package Description Date Date NDC:4228 3-0 45- 50 mL in 1 BOTTLE, WITH APPLICATOR; Type 0 : No t a 1 0 7/0 1/20 20 0 0 Co mbinatio n Pro duct

Marketing Information Marke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date OTC mo no graph final part350 0 7/0 1/20 20

Labeler - AC MARCA PERSONAL CARE, S.L. (460005267)

Establishment Name Addre ss ID/FEI Busine ss Ope rations Labo rato rio Geno ve, S.A. 46 49 55435 manufacture(4228 3-0 45)

Revised: 6/2020 AC MARCA PERSONAL CARE, S.L.