SAFE HAIR by OLLA BOTANICAL COSMETIC IND. E COM. IMPORTACAO E EXPORTACAO EIRELI / OLLA BOTANICAL COSMETIC IND. E COM. IMPORTACAO E EXPORTACAO EIRELI Safe Hair BZK Spray

Drug Details [pdf]

SAFE HAIR- instant cleansing spray spray
OLLA BOTANICAL COSMETIC IND. E COM. IMPORTACAO E EXPORTACAO EIRELI

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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Safe Hair BZK Spray

Active Ingredient(s)

Benzalkonium chloride 0.1 %

Purpose

Antiseptic

Use

For sanitizing and to help reduce bacteria on the hair and the skin.

Warnings

For external use only.

Do not use

in or near the eyes or on open skin wounds or burns
on children under 3 years of age

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

Directions

Shake well before use it. Spray all over the hair or beard and comb through hair for uniform product distribution. No Rinse. Daily Use. For all hair types. Also, spray on the hands and let it dry.
Children under 6 years of age should be supervised when using this product.

Other information

Avoid freezing and store below 110F (43C).

Inactive ingredients

aloe vera leaf, citral, cocoyl caprylocaprate, east indian lemongrass, ethyl alcohol, eugenol, geraniol, glycerin, limonene, linalool, melaleuca alternifolia leaf, peg-7 glyceryl, potassium sorbate, salicylic acid, water, zinc pca.

Package Label - Principal Display Panel

150 mL NDC: <a href=/NDC/78727-122-15>78727-122-15</a> 150 mL NDC: 78727-122-15

SAFE HAIR
instant cleansing spray spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78727-122
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.1 mg in 100 mL

Ingredient Name	Strength
Inactive Ingredients
EAST INDIAN LEMONGRASS OIL (UNII: UP0M8M3VZW)
EUGENOL (UNII: 3T8H1794QW)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
ALCOHOL (UNII: 3K9958V90M)
GERANIOL (UNII: L837108USY)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
ZINC PIDOLATE (UNII: C32PQ86DH4)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
TEA TREE OIL (UNII: VIF565UC2G)
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)
SALICYLIC ACID (UNII: O414PZ4LPZ)
CITRAL (UNII: T7EU0O9VPP)
COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 78727-122-15	150 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/28/2020
2	NDC: 78727-122-20	200 mL in 1 PACKAGE; Type 0: Not a Combination Product	06/28/2020
3	NDC: 78727-122-50	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/28/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	06/28/2020	06/07/2021

Labeler - OLLA BOTANICAL COSMETIC IND. E COM. IMPORTACAO E EXPORTACAO EIRELI (894228823)

Name	Address	ID/FEI	Business Operations
Establishment
OLLA BOTANICAL COSMETIC IND. E COM. IMPORTACAO E EXPORTACAO EIRELI		894228823	manufacture(78727-122)

Revised: 6/2021

Document Id: c4333d1f-6cc2-0090-e053-2995a90a0f61

Set id: a9209184-34b8-ae5d-e053-2995a90a1cab

Version: 2

Effective Time: 20210607

OLLA BOTANICAL COSMETIC IN